Trial Outcomes & Findings for A Phase 3 Study of Fluvoxamine (SME3110) in Pediatric/Adolescent Patients With Obsessive Compulsive Disorder (NCT NCT01933919)

NCT ID: NCT01933919

Last Updated: 2017-12-04

Results Overview

The Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) is a 10-item questionnaire assessing the severity of obsessive compulsive disorder (OCD) in the past 7 days. Severity of compulsions and obsessions are rated on a scale from 0 (none) to 4 (extreme). The total score is calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

38 participants

Primary outcome timeframe

Baseline and week 10

Results posted on

2017-12-04

Participant Flow

This study was conducted at 34 clinical sites in Japan.

Eligible participants were randomized to placebo or fluvoxamine in a 1:1 ratio. Randomization was stratified by prior fluvoxamine treatment and age (6-11 years or 12-18 years).

Participant milestones

Participant milestones
Measure	Fluvoxamine In the double-blind placebo-controlled phase participants received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week. In the open-label long-term phase participants received 25 mg fluvoxamine once a day for the first week, 25 mg BID in week 2 followed by a flexible dose period from weeks 3 to 52 where the dose could be escalated by 25 mg/day/week up to a maximum dose of 150 mg/day (three tablets BID). At the end of the 52-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to 50 mg/day each week.	Placebo In the double-blind placebo-controlled phase participants received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week. In the open-label long-term phase participants received 25 mg fluvoxamine once a day for the first week, 25 mg BID in week 2 followed by a flexible dose period from weeks 3 to 52 where the dose could be escalated by one tablet/day/week up to a maximum of 150 mg/day (three tablets BID). At the end of the 52-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to 50 mg/day each week.
Double-blind Placebo-controlled Phase STARTED	19	19
Double-blind Placebo-controlled Phase Received Study Drug	19	19
Double-blind Placebo-controlled Phase COMPLETED	19	15
Double-blind Placebo-controlled Phase NOT COMPLETED	0	4
Open-label Long-term Phase STARTED	19	15
Open-label Long-term Phase COMPLETED	12	9
Open-label Long-term Phase NOT COMPLETED	7	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Fluvoxamine In the double-blind placebo-controlled phase participants received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week. In the open-label long-term phase participants received 25 mg fluvoxamine once a day for the first week, 25 mg BID in week 2 followed by a flexible dose period from weeks 3 to 52 where the dose could be escalated by 25 mg/day/week up to a maximum dose of 150 mg/day (three tablets BID). At the end of the 52-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to 50 mg/day each week.	Placebo In the double-blind placebo-controlled phase participants received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week. In the open-label long-term phase participants received 25 mg fluvoxamine once a day for the first week, 25 mg BID in week 2 followed by a flexible dose period from weeks 3 to 52 where the dose could be escalated by one tablet/day/week up to a maximum of 150 mg/day (three tablets BID). At the end of the 52-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to 50 mg/day each week.
Double-blind Placebo-controlled Phase Adverse Event	0	1
Double-blind Placebo-controlled Phase Withdrawal by Subject	0	1
Double-blind Placebo-controlled Phase Lack of Efficacy	0	2
Open-label Long-term Phase Adverse Event	2	0
Open-label Long-term Phase Withdrawal by Subject	3	4
Open-label Long-term Phase Lost to Follow-up	1	0
Open-label Long-term Phase Other	1	2

Baseline Characteristics

A Phase 3 Study of Fluvoxamine (SME3110) in Pediatric/Adolescent Patients With Obsessive Compulsive Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fluvoxamine n=19 Participants In the double-blind placebo-controlled phase participants received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week. In the open-label long-term phase participants received 25 mg fluvoxamine once a day for the first week, 25 mg BID in week 2 followed by a flexible dose period from weeks 3 to 52 where the dose could be escalated by 25 mg/day/week up to a maximum dose of 150 mg/day (three tablets BID). At the end of the 52-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to 50 mg/day each week.	Placebo n=18 Participants In the double-blind placebo-controlled phase participants received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week. In the open-label long-term phase participants received 25 mg fluvoxamine once a day for the first week, 25 mg BID in week 2 followed by a flexible dose period from weeks 3 to 52 where the dose could be escalated by one tablet/day/week up to a maximum of 150 mg/day (three tablets BID). At the end of the 52-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to 50 mg/day each week.	Total n=37 Participants Total of all reporting groups
Age, Continuous	13.7 years STANDARD_DEVIATION 2.83 • n=5 Participants	13.3 years STANDARD_DEVIATION 2.72 • n=7 Participants	13.5 years STANDARD_DEVIATION 2.74 • n=5 Participants
Age, Customized 6-11 years	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Age, Customized 12-18 years	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized Japanese	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Prior Treatment with Fluvoxamine Yes	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Prior Treatment with Fluvoxamine No	19 Participants n=5 Participants	17 Participants n=7 Participants	36 Participants n=5 Participants
Japanese version of the Children's Yale-Brown Obsessive Total Score	25.4 units on a scale STANDARD_DEVIATION 5.92 • n=5 Participants	27.1 units on a scale STANDARD_DEVIATION 5.48 • n=7 Participants	26.2 units on a scale STANDARD_DEVIATION 5.69 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and week 10

Population: Full analysis set for the 1st phase; last observation carried forward imputation was used.

Outcome measures

Outcome measures
Measure	Fluvoxamine n=19 Participants In the double-blind placebo-controlled phase participants received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.	Placebo n=18 Participants In the double-blind placebo-controlled phase participants received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.	Fluvoxamine - Ages 12-18 In the double-blind placebo-controlled phase participants aged 12 to 18 years received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.	Placebo - Ages 12-18 In the double-blind placebo-controlled phase participants aged 12 to 18 years received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.
Mean Change From Baseline in the Japanese Children's Yale-Brown Obsessive Compulsive Scale 10-item Total Score at the End of Treatment in the First Phase	-10.5 units on a scale Standard Deviation 5.25	-6.6 units on a scale Standard Deviation 7.52	—	—

SECONDARY outcome

Timeframe: Baseline and week 10

Population: Full analysis set for the first phase; last observation carried forward imputation was used.

Outcome measures

Outcome measures
Measure	Fluvoxamine n=4 Participants In the double-blind placebo-controlled phase participants received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.	Placebo n=4 Participants In the double-blind placebo-controlled phase participants received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.	Fluvoxamine - Ages 12-18 n=15 Participants In the double-blind placebo-controlled phase participants aged 12 to 18 years received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.	Placebo - Ages 12-18 n=14 Participants In the double-blind placebo-controlled phase participants aged 12 to 18 years received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.
Mean Change From Baseline in the JCY-BOCS 10-item Total Score at the End of Treatment in the First Phase Stratified by Age	-12.5 units on a scale Standard Deviation 3.00	-10.3 units on a scale Standard Deviation 11.95	-10.0 units on a scale Standard Deviation 5.67	-5.6 units on a scale Standard Deviation 5.97

SECONDARY outcome

Timeframe: Baseline and week 10

Population: Full analysis set for the 1st phase; last observation carried forward imputation was used.

Outcome measures

Outcome measures
Measure	Fluvoxamine n=9 Participants In the double-blind placebo-controlled phase participants received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.	Placebo n=11 Participants In the double-blind placebo-controlled phase participants received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.	Fluvoxamine - Ages 12-18 n=10 Participants In the double-blind placebo-controlled phase participants aged 12 to 18 years received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.	Placebo - Ages 12-18 n=7 Participants In the double-blind placebo-controlled phase participants aged 12 to 18 years received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.
Mean Change From Baseline in the JCY-BOCS 10-item Total Score at the End of Treatment in the First Phase Stratified by Gender	-11.9 units on a scale Standard Deviation 4.68	-7.0 units on a scale Standard Deviation 8.38	-9.3 units on a scale Standard Deviation 5.68	-6.0 units on a scale Standard Deviation 6.51

SECONDARY outcome

Timeframe: Baseline and weeks 2, 4, 6, 8 and 10

Population: Full analysis set for the 1st phase; participants with available data at each time point.

Outcome measures

Outcome measures
Measure	Fluvoxamine n=19 Participants In the double-blind placebo-controlled phase participants received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.	Placebo n=18 Participants In the double-blind placebo-controlled phase participants received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.	Fluvoxamine - Ages 12-18 In the double-blind placebo-controlled phase participants aged 12 to 18 years received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.	Placebo - Ages 12-18 In the double-blind placebo-controlled phase participants aged 12 to 18 years received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.
Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the First Phase Week 2	-3.9 units on a scale Standard Deviation 3.49	-1.6 units on a scale Standard Deviation 2.29	—	—
Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the First Phase Week 4	-5.1 units on a scale Standard Deviation 4.95	-3.2 units on a scale Standard Deviation 4.48	—	—
Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the First Phase Week 6	-8.8 units on a scale Standard Deviation 6.31	-5.6 units on a scale Standard Deviation 5.44	—	—
Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the First Phase Week 8	-8.6 units on a scale Standard Deviation 5.01	-7.9 units on a scale Standard Deviation 8.39	—	—
Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the First Phase Week 10	-10.8 units on a scale Standard Deviation 5.29	-7.2 units on a scale Standard Deviation 7.77	—	—

SECONDARY outcome

Timeframe: Baseline and weeks 2, 4, 6, 8 and 10

Population: Full analysis set for the first phase; participants with available data at each time point. Last observation carried forward imputation was used for the last post-baseline visit assessment.

Outcome measures

Outcome measures
Measure	Fluvoxamine n=19 Participants In the double-blind placebo-controlled phase participants received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.	Placebo n=18 Participants In the double-blind placebo-controlled phase participants received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.	Fluvoxamine - Ages 12-18 In the double-blind placebo-controlled phase participants aged 12 to 18 years received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.	Placebo - Ages 12-18 In the double-blind placebo-controlled phase participants aged 12 to 18 years received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.
JCY-BOCS 10-item Total Score at Each Visit During the First Phase Baseline	26.6 units on a scale Standard Deviation 5.51	27.3 units on a scale Standard Deviation 5.26	—	—
JCY-BOCS 10-item Total Score at Each Visit During the First Phase Week 2	22.7 units on a scale Standard Deviation 6.72	25.1 units on a scale Standard Deviation 5.83	—	—
JCY-BOCS 10-item Total Score at Each Visit During the First Phase Week 4	21.5 units on a scale Standard Deviation 7.91	24.2 units on a scale Standard Deviation 6.89	—	—
JCY-BOCS 10-item Total Score at Each Visit During the First Phase Week 6	17.4 units on a scale Standard Deviation 7.48	22.1 units on a scale Standard Deviation 8.24	—	—
JCY-BOCS 10-item Total Score at Each Visit During the First Phase Week 8	17.9 units on a scale Standard Deviation 6.27	19.6 units on a scale Standard Deviation 10.46	—	—
JCY-BOCS 10-item Total Score at Each Visit During the First Phase Week 10	15.4 units on a scale Standard Deviation 6.48	20.7 units on a scale Standard Deviation 9.80	—	—
JCY-BOCS 10-item Total Score at Each Visit During the First Phase Last post-baseline visit	16.1 units on a scale Standard Deviation 6.84	20.7 units on a scale Standard Deviation 9.21	—	—

SECONDARY outcome

Timeframe: Weeks 1, 2, 3, 4, 5, 6, 8, and 10

The investigator evaluated Clinical Global Impression (CGI) to rate participants' clinical symptomatology according to the following seven categories at each visit compared to the day of the first dose of study medication: 1. Very much improved 2. Much improved 3. Minimally improved 4. No change 5. Minimally worse 6. Worse 7. Very much worse Much improved includes CGI score categories 'very much improved' and 'much improved'.

Outcome measures

Outcome measures
Measure	Fluvoxamine n=19 Participants In the double-blind placebo-controlled phase participants received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.	Placebo n=18 Participants In the double-blind placebo-controlled phase participants received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.	Fluvoxamine - Ages 12-18 In the double-blind placebo-controlled phase participants aged 12 to 18 years received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.	Placebo - Ages 12-18 In the double-blind placebo-controlled phase participants aged 12 to 18 years received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.
Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the First Phase Week 1	0.0 percentage of participants	0.0 percentage of participants	—	—
Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the First Phase Week 2	5.3 percentage of participants	0.0 percentage of participants	—	—
Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the First Phase Week 3	5.3 percentage of participants	11.1 percentage of participants	—	—
Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the First Phase Week 4	10.5 percentage of participants	5.9 percentage of participants	—	—
Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the First Phase Week 5	26.3 percentage of participants	5.9 percentage of participants	—	—
Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the First Phase Week 6	38.9 percentage of participants	29.4 percentage of participants	—	—
Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the First Phase Week 8	42.1 percentage of participants	43.8 percentage of participants	—	—
Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the First Phase Week 10	50.0 percentage of participants	43.8 percentage of participants	—	—
Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the First Phase Last post-baseline visit	52.6 percentage of participants	38.9 percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline and week 10

Population: Full analysis set for the first phase; last observation carried forward imputation was used.

Outcome measures

Outcome measures
Measure	Fluvoxamine n=19 Participants In the double-blind placebo-controlled phase participants received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.	Placebo n=18 Participants In the double-blind placebo-controlled phase participants received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.	Fluvoxamine - Ages 12-18 In the double-blind placebo-controlled phase participants aged 12 to 18 years received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.	Placebo - Ages 12-18 In the double-blind placebo-controlled phase participants aged 12 to 18 years received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.
Percentage of Participants With a ≥ 25% Decrease From Baseline in JCY-BOCS (10-item) Total Score at the End of Treatment in the First Phase	73.7 percentage of participants	44.4 percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline and week 10

Population: Full analysis set for the first phase; last observation carried forward imputation was used.

Outcome measures

Outcome measures
Measure	Fluvoxamine n=19 Participants In the double-blind placebo-controlled phase participants received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.	Placebo n=18 Participants In the double-blind placebo-controlled phase participants received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.	Fluvoxamine - Ages 12-18 In the double-blind placebo-controlled phase participants aged 12 to 18 years received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.	Placebo - Ages 12-18 In the double-blind placebo-controlled phase participants aged 12 to 18 years received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.
Percentage of Participants With a ≥ 35% Decrease From Baseline in JCY-BOCS (10-item) Total Score at the End of Treatment in the First Phase	68.4 percentage of participants	33.3 percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline of the 2nd phase and weeks 2, 8, 16, 28, 40, and 52 of the 2nd phase

Population: The full analysis set (FAS) for the 2nd phase (FAS2) included participants who received at least one dose of study drug, and had a baseline and at last one post-baseline measurement for efficacy after week 1 in the 2nd phase. Last observation carried forward imputation was used for the last post-baseline visit assessment.

The Japanese version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) is a 10-item questionnaire assessing the severity of OCD in the past 7 days. Severity of compulsions and obsessions are rated on a scale from 0 (none) to 4 (extreme). The total score is calculated by summing the 10 individual scores and ranges from 0 to 40, where higher scores indicate more extreme symptoms. Baseline for the 2nd phase was the first visit of the 2nd phase after completion of the tapering period in the first phase and prior to study drug administration in the 2nd phase.

Outcome measures

Outcome measures
Measure	Fluvoxamine n=18 Participants In the double-blind placebo-controlled phase participants received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.	Placebo n=15 Participants In the double-blind placebo-controlled phase participants received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.	Fluvoxamine - Ages 12-18 In the double-blind placebo-controlled phase participants aged 12 to 18 years received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.	Placebo - Ages 12-18 In the double-blind placebo-controlled phase participants aged 12 to 18 years received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.
Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the Second Phase Change from baseline at week 8	-1.2 units on a scale Standard Deviation 2.87	-4.3 units on a scale Standard Deviation 7.54	—	—
Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the Second Phase Change from baseline at week 16	-1.3 units on a scale Standard Deviation 2.95	-7.1 units on a scale Standard Deviation 8.53	—	—
Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the Second Phase Change from baseline at week 2	-0.2 units on a scale Standard Deviation 3.93	-1.1 units on a scale Standard Deviation 6.55	—	—
Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the Second Phase Baseline of 2nd phase	14.8 units on a scale Standard Deviation 6.62	20.4 units on a scale Standard Deviation 9.81	—	—
Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the Second Phase Change from baseline at week 28	-0.7 units on a scale Standard Deviation 3.87	-6.2 units on a scale Standard Deviation 6.13	—	—
Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the Second Phase Change from baseline at week 40	-1.9 units on a scale Standard Deviation 3.97	-5.6 units on a scale Standard Deviation 11.02	—	—
Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the Second Phase Change from baseline at week 52	-3.1 units on a scale Standard Deviation 4.48	-6.6 units on a scale Standard Deviation 9.15	—	—
Mean Change From Baseline in the JCY-BOCS 10-item Total Score at Each Visit During the Second Phase Change from baseline at last post-baseline visit	-1.7 units on a scale Standard Deviation 5.48	-8.1 units on a scale Standard Deviation 8.61	—	—

SECONDARY outcome

Timeframe: Baseline of the 2nd phase and weeks 1, 2, 3, 4, 5, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52

Population: Full analysis set for the 2nd phase; last observation carried forward imputation was used for the last post-baseline visit assessment.

The investigator evaluated Clinical Global Impression (CGI) to rate participants' clinical symptomatology according to the following seven categories at each visit compared to the day of the first dose of study medication in the 2nd phase: 1. Very much improved 2. Much improved 3. Minimally improved 4. No change 5. Minimally worse 6. Worse 7. Very much worse Much improved includes CGI score categories 'very much improved' and 'much improved'.

Outcome measures

Outcome measures
Measure	Fluvoxamine n=19 Participants In the double-blind placebo-controlled phase participants received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.	Placebo n=15 Participants In the double-blind placebo-controlled phase participants received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.	Fluvoxamine - Ages 12-18 In the double-blind placebo-controlled phase participants aged 12 to 18 years received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.	Placebo - Ages 12-18 In the double-blind placebo-controlled phase participants aged 12 to 18 years received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.
Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase Week 1	22.2 percentage of participants	7.1 percentage of participants	—	—
Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase Week 2	5.6 percentage of participants	20.0 percentage of participants	—	—
Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase Week 3	12.5 percentage of participants	35.7 percentage of participants	—	—
Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase Week 4	16.7 percentage of participants	33.3 percentage of participants	—	—
Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase Week 5	23.5 percentage of participants	54.5 percentage of participants	—	—
Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase Week 6	22.2 percentage of participants	46.7 percentage of participants	—	—
Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase Week 8	33.3 percentage of participants	60.0 percentage of participants	—	—
Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase Week 12	29.4 percentage of participants	53.3 percentage of participants	—	—
Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase Week 16	35.7 percentage of participants	64.3 percentage of participants	—	—
Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase Week 20	50.0 percentage of participants	64.3 percentage of participants	—	—
Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase Week 24	42.9 percentage of participants	53.8 percentage of participants	—	—
Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase Week 28	64.3 percentage of participants	58.3 percentage of participants	—	—
Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase Week 32	57.1 percentage of participants	40.0 percentage of participants	—	—
Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase Week 36	50.0 percentage of participants	27.3 percentage of participants	—	—
Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase Week 40	61.5 percentage of participants	25.0 percentage of participants	—	—
Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase Week 44	50.0 percentage of participants	45.5 percentage of participants	—	—
Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase Week 48	50.0 percentage of participants	27.3 percentage of participants	—	—
Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase Week 52	57.1 percentage of participants	36.4 percentage of participants	—	—
Percentage of Participants Much Improved in Clinical Global Impression Improvement Assessment During the Second Phase Last post-baseline visit	42.1 percentage of participants	46.7 percentage of participants	—	—

SECONDARY outcome

Timeframe: From the first dose of the study drug up to 30 days after the last dose of the study drug, approximately 18 weeks in the first phase.

Population: Participants who received the study drug at least once in the first phase

An adverse event (AE) was assessed as treatment-related by the investigator if there was evidence to suggest a causal relationship between the study drug and the adverse event. The investigator used the following definitions to rate the severity of each adverse event: Mild: The adverse event was transient and easily tolerated by the participant; Moderate: The adverse event caused the participant discomfort and interrupted usual activities. Severe: The adverse event caused considerable interference with the participant's usual activities and may have been incapacitating or life-threatening. A serious adverse event was any event that resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, congenital anomaly, persistent or significant disability/incapacity, or was an important medical event requiring medical or surgical intervention to prevent a serious outcome.

Outcome measures

Outcome measures
Measure	Fluvoxamine n=19 Participants In the double-blind placebo-controlled phase participants received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.	Placebo n=19 Participants In the double-blind placebo-controlled phase participants received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.	Fluvoxamine - Ages 12-18 In the double-blind placebo-controlled phase participants aged 12 to 18 years received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.	Placebo - Ages 12-18 In the double-blind placebo-controlled phase participants aged 12 to 18 years received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.
Number of Participants With Adverse Events During the First Phase Treatment-related adverse event	6 participants	5 participants	—	—
Number of Participants With Adverse Events During the First Phase Any adverse event	13 participants	15 participants	—	—
Number of Participants With Adverse Events During the First Phase Severe adverse event	0 participants	0 participants	—	—
Number of Participants With Adverse Events During the First Phase Serious adverse events	0 participants	0 participants	—	—
Number of Participants With Adverse Events During the First Phase AE leading to discontinuation of study drug	0 participants	1 participants	—	—
Number of Participants With Adverse Events During the First Phase AE leading to death	0 participants	0 participants	—	—

SECONDARY outcome

Timeframe: From the first dose of the study drug up to 30 days after the last dose of the study drug, approximately 60 weeks in the second phase of the study.

Population: Participants who received the study drug at least once in the second phase.

An adverse event was assessed as treatment-related by the investigator if there was evidence to suggest a causal relationship between the study drug and the adverse event. The investigator used the following definitions to rate the severity of each adverse event: Mild: The adverse event was transient and easily tolerated by the participant; Moderate: The adverse event caused the participant discomfort and interrupted usual activities. Severe: The adverse event caused considerable interference with the participant's usual activities and may have been incapacitating or life-threatening. A serious adverse event was any event that resulted in death, was life-threatening, resulted in hospitalization or prolongation of hospitalization, congenital anomaly, persistent or significant disability/incapacity, or was an important medical event requiring medical or surgical intervention to prevent a serious outcome.

Outcome measures

Outcome measures
Measure	Fluvoxamine n=19 Participants In the double-blind placebo-controlled phase participants received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.	Placebo n=15 Participants In the double-blind placebo-controlled phase participants received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.	Fluvoxamine - Ages 12-18 In the double-blind placebo-controlled phase participants aged 12 to 18 years received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.	Placebo - Ages 12-18 In the double-blind placebo-controlled phase participants aged 12 to 18 years received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.
Number of Participants With Adverse Events During the Second Phase Any adverse event	15 participants	15 participants	—	—
Number of Participants With Adverse Events During the Second Phase Treatment-related adverse event	7 participants	7 participants	—	—
Number of Participants With Adverse Events During the Second Phase Severe adverse event	0 participants	0 participants	—	—
Number of Participants With Adverse Events During the Second Phase Serious adverse event	0 participants	1 participants	—	—
Number of Participants With Adverse Events During the Second Phase AE leading to discontinuation of study drug	2 participants	0 participants	—	—
Number of Participants With Adverse Events During the Second Phase AE leading to death	0 participants	0 participants	—	—

Adverse Events

First Phase: Fluvoxamine

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

First Phase: Placebo

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Second Phase: Fluvoxamine/Fluvoxamine

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Second Phase: Placebo/Fluvoxamine

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	First Phase: Fluvoxamine n=19 participants at risk In the double-blind placebo-controlled phase participants received 25 mg fluvoxamine once a day in week 1, 25 mg twice a day (BID) in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by 25 mg/day/week up to a maximum of 150 mg (three tablets BID). From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose of decreased by up to 50 mg/day each week.	First Phase: Placebo n=19 participants at risk In the double-blind placebo-controlled phase participants received one placebo tablet a day in week 1, then one placebo tablet BID in week 2 followed by a dose adjustment period from weeks 3 to 6 where the dose could be escalated by one tablet/day/week up to a maximum dose of three tablets BID. From weeks 7 to 10 participants received the same dose that was given in week 6. At the end of the 10-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to two tablets/day each week.	Second Phase: Fluvoxamine/Fluvoxamine n=19 participants at risk In the open-label long-term phase participants who received fluvoxamine in the first phase then received 25 mg fluvoxamine once a day for the first week, 25 mg fluvoxamine BID in week 2 followed by a flexible dose period from weeks 3 to 52 where the dose could be escalated by 25 mg/day/week up to a maximum dose of 150 mg/day (three tablets BID). At the end of the 52-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to 50 mg/day each week.	Second Phase: Placebo/Fluvoxamine n=15 participants at risk In the open-label long-term phase participants who received placebo in the first phase then received 25 mg fluvoxamine once a day for the first week, 25 mg fluvoxamine BID in week 2 followed by a flexible dose period from weeks 3 to 52 where the dose could be escalated by one tablet/day/week up to a maximum of 150 mg/day (three tablets BID). At the end of the 52-week treatment period there was a dose-tapering period of up to 4 weeks where the dose was decreased by up to 50 mg/day each week.
Respiratory, thoracic and mediastinal disorders Hyperventilation	0.00% 0/19 • From the first dose of the study drug up to 30 days after the last dose of the study drug, approximately18 weeks in the first phase of the study and 60 weeks in the second phase.	0.00% 0/19 • From the first dose of the study drug up to 30 days after the last dose of the study drug, approximately18 weeks in the first phase of the study and 60 weeks in the second phase.	0.00% 0/19 • From the first dose of the study drug up to 30 days after the last dose of the study drug, approximately18 weeks in the first phase of the study and 60 weeks in the second phase.	6.7% 1/15 • From the first dose of the study drug up to 30 days after the last dose of the study drug, approximately18 weeks in the first phase of the study and 60 weeks in the second phase.

Other adverse events

Additional Information

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