Trial Outcomes & Findings for Duloxetine for the Treatment of Obsessive Compulsive Disorder (OCD) (NCT NCT00464698)

Results Overview

OCD symptom change. This is the intention-to-treat analyses (with all 20 subjects included) rather than just the subjects who completed the treatment.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

20 participants

Primary outcome timeframe

Week 0 to 17

Results posted on

2019-03-19

Participant Flow

Participant milestones

Participant milestones
Measure	All Study Participants Duloxetine Week 1 dose: 30mg Duloxetine Weeks 2-4 dose: 60mg Duloxetine Weeks 5-17 dose: 120mg
Period 1: 30 mg STARTED	20
Period 1: 30 mg COMPLETED	17
Period 1: 30 mg NOT COMPLETED	3
Period 2: 60 mg STARTED	17
Period 2: 60 mg COMPLETED	17
Period 2: 60 mg NOT COMPLETED	0
Period 3: 120mg STARTED	14
Period 3: 120mg COMPLETED	12
Period 3: 120mg NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Duloxetine for the Treatment of Obsessive Compulsive Disorder (OCD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Duloxetine n=20 Participants Duloxetine: Week 1 dose: 30mg, Weeks 2-4 dose: 60mg, Weeks 5-17 dose: 120mg
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	29.90 years STANDARD_DEVIATION 10.66 • n=5 Participants
Age, Customized Age of OCD onset	15.35 years STANDARD_DEVIATION 10.479 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants
Yale-Brown Obsessive Compulsive Scale (YBOCS)	27.45 units on a scale STANDARD_DEVIATION 4.08 • n=5 Participants
Duration of illness	14.80 years STANDARD_DEVIATION 12.88 • n=5 Participants

PRIMARY outcome

Timeframe: Week 0 to 17

OCD symptom change. This is the intention-to-treat analyses (with all 20 subjects included) rather than just the subjects who completed the treatment.

Outcome measures

Outcome measures
Measure	Duloxetine n=20 Participants Duloxetine: Week 1 dose: 30mg, Weeks 2-4 dose: 60mg, Weeks 5-17 dose: 120mg
Y-BOCS Scores at 1st and Last Visit Baseline YBOCS score	27.45 units on a scale Standard Deviation 4.08
Y-BOCS Scores at 1st and Last Visit Final YBOCS score	20.45 units on a scale Standard Deviation 7.57

SECONDARY outcome

Timeframe: Week 0 to 17

Population: 20 participants with OCD were enrolled in a 17-week, open label treatment trial with duloxetine.

Depression severity, such that higher scores on the BDI are reflective of more severe depression. BDI minimum score: 0 MDI maximum score: 63

Outcome measures

Outcome measures
Measure	Duloxetine n=20 Participants Duloxetine: Week 1 dose: 30mg, Weeks 2-4 dose: 60mg, Weeks 5-17 dose: 120mg
BDI (Beck Depression Inventory) - First and Last Visit (Week 0 and Week 17). Baseline BDI (Week 0)	10.30 units on a self-report questionnaire Standard Deviation 6.98
BDI (Beck Depression Inventory) - First and Last Visit (Week 0 and Week 17). Final Visit BDI (Week 17)	6.95 units on a self-report questionnaire Standard Deviation 6.10

SECONDARY outcome

Timeframe: Week 0 to 17

Population: 20 participants with OCD were enrolled in a 17-week, open label treatment trial with duloxetine.

Anxiety severity, such that a higher score on the BAI reflects more severe anxiety. Minimum value: 0 Maximum value: 63

Outcome measures

Outcome measures
Measure	Duloxetine n=20 Participants Duloxetine: Week 1 dose: 30mg, Weeks 2-4 dose: 60mg, Weeks 5-17 dose: 120mg
BAI (Beck Anxiety Inventory) - First and Last Visit (Week 0 and Week 17) Baseline BAI (Week 0)	10.70 units on a self-report questionnaire Standard Deviation 11.54
BAI (Beck Anxiety Inventory) - First and Last Visit (Week 0 and Week 17) Final Visit BAI (Week 17)	6.75 units on a self-report questionnaire Standard Deviation 7.05

SECONDARY outcome

Timeframe: Week 0 to 17

Population: 20 participants with OCD were enrolled in a 17-week, open label treatment trial with duloxetine.

Quality of life, such that lower score reflects poorer quality of life Minimum score: 16 Maximum score: 80

Outcome measures

Outcome measures
Measure	Duloxetine n=20 Participants Duloxetine: Week 1 dose: 30mg, Weeks 2-4 dose: 60mg, Weeks 5-17 dose: 120mg
QLESQ (Quality of Life, Enjoyment, and Satisfaction Questionnaire) - First and Last Visit (Week 0 and Week 17) Baseline Q-LES-Q (Week 0)	70.14 units on a self-report questionnaire Standard Deviation 14.03
QLESQ (Quality of Life, Enjoyment, and Satisfaction Questionnaire) - First and Last Visit (Week 0 and Week 17) Final Visit Q-LES-Q (Week 17)	74.55 units on a self-report questionnaire Standard Deviation 12.03

SECONDARY outcome

Timeframe: Week 3 to 17

Population: 20 participants with OCD were enrolled in a 17-week, open label treatment trial with duloxetine.

Global severity of illness, such that a higher score reflects worse global severity Minimum score: 2 Maximum score: 14

Outcome measures

Outcome measures
Measure	Duloxetine n=20 Participants Duloxetine: Week 1 dose: 30mg, Weeks 2-4 dose: 60mg, Weeks 5-17 dose: 120mg
Clinical Global Impressions Scale at Week 3 and Week 17 Baseline CGI (Week 3)	4.0 units on a self-report questionnaire Standard Deviation 0
Clinical Global Impressions Scale at Week 3 and Week 17 Final Visit CGI (Week 17)	2.70 units on a self-report questionnaire Standard Deviation .923

Adverse Events

Duloxetine: Week 1 Dose: 30mg

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Duloxetine Weeks 2-4 Dose: 60mg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Duloxetine Weeks 5-17 Dose: 120mg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Duloxetine: Week 1 Dose: 30mg n=20 participants at risk	Duloxetine Weeks 2-4 Dose: 60mg n=17 participants at risk	Duloxetine Weeks 5-17 Dose: 120mg n=14 participants at risk
Gastrointestinal disorders nausea	50.0% 10/20 • Number of events 10	17.6% 3/17 • Number of events 3	28.6% 4/14 • Number of events 4
General disorders fatigue	25.0% 5/20 • Number of events 5	29.4% 5/17 • Number of events 5	42.9% 6/14 • Number of events 6
Reproductive system and breast disorders sexual dysfunction	10.0% 2/20 • Number of events 2	23.5% 4/17 • Number of events 4	21.4% 3/14 • Number of events 3
General disorders headache	10.0% 2/20 • Number of events 2	0.00% 0/17	7.1% 1/14 • Number of events 1

Additional Information

Darin D. Dougherty, MD

Massachusetts General Hospital

Phone: 617-724-6300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place