Trial Outcomes & Findings for Adult Attention Deficit Hyperactivity Disorder (NCT NCT01692782)
NCT ID: NCT01692782
Last Updated: 2015-01-12
Results Overview
The ADHD RS-IV with adult prompts is an 18 item scale based on the DSM IV TR criteria for ADHD that provides a rating of the severity symptoms. Scoring is based on a 4 point Likert-type severity scale where 0 = none, 1 = mild, 2 = moderate, and 3 = severe. Clinicians scored the highest score that was generated for the prompts for each item. The ADHD rating scale total score is defined as sum of all 18 item scale scores.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
341 participants
Primary outcome timeframe
4 Weeks
Results posted on
2015-01-12
Participant Flow
Participant milestones
| Measure |
SEP-225289 4mg
SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses
SEP-225289: SEP-225289 4mg once daily
SEP-225289: SEP-225289 8mg once daily
|
SEP-225289 8mg
SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses
SEP-225289: SEP-225289 4mg once daily
SEP-225289: SEP-225289 8mg once daily
|
Placebo
4 capsules of placebo
Placebo: Placebo once daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
116
|
115
|
110
|
|
Overall Study
COMPLETED
|
96
|
59
|
100
|
|
Overall Study
NOT COMPLETED
|
20
|
56
|
10
|
Reasons for withdrawal
| Measure |
SEP-225289 4mg
SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses
SEP-225289: SEP-225289 4mg once daily
SEP-225289: SEP-225289 8mg once daily
|
SEP-225289 8mg
SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses
SEP-225289: SEP-225289 4mg once daily
SEP-225289: SEP-225289 8mg once daily
|
Placebo
4 capsules of placebo
Placebo: Placebo once daily
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
12
|
32
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
7
|
1
|
|
Overall Study
Pregnancy
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
2
|
|
Overall Study
Non-complance with study drug
|
0
|
4
|
1
|
|
Overall Study
Non-compliant with study visits
|
0
|
0
|
1
|
|
Overall Study
SAE not related to study drug
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
10
|
3
|
Baseline Characteristics
Adult Attention Deficit Hyperactivity Disorder
Baseline characteristics by cohort
| Measure |
SEP-225289 4mg
n=114 Participants
SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses
SEP-225289: SEP-225289 4mg once daily
|
SEP-225289 8mg
n=107 Participants
SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses
SEP-225289: SEP-225289 8mg once daily
|
Placebo
n=110 Participants
4 capsules of placebo
Placebo: Placebo once daily
|
Total
n=331 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
114 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
331 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
34.2 Years
STANDARD_DEVIATION 10.06 • n=5 Participants
|
34.5 Years
STANDARD_DEVIATION 11.15 • n=7 Participants
|
33.9 Years
STANDARD_DEVIATION 11.03 • n=5 Participants
|
34.2 Years
STANDARD_DEVIATION 10.71 • n=4 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
137 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
194 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
114 participants
n=5 Participants
|
107 participants
n=7 Participants
|
110 participants
n=5 Participants
|
331 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 4 WeeksPopulation: Intent to treat population
The ADHD RS-IV with adult prompts is an 18 item scale based on the DSM IV TR criteria for ADHD that provides a rating of the severity symptoms. Scoring is based on a 4 point Likert-type severity scale where 0 = none, 1 = mild, 2 = moderate, and 3 = severe. Clinicians scored the highest score that was generated for the prompts for each item. The ADHD rating scale total score is defined as sum of all 18 item scale scores.
Outcome measures
| Measure |
SEP-225289 4mg
n=114 Participants
SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses
SEP-225289: SEP-225289 4mg once daily
SEP-225289: SEP-225289 8mg once daily
|
SEP-225289 8mg
n=107 Participants
SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses
SEP-225289: SEP-225289 4mg once daily
SEP-225289: SEP-225289 8mg once daily
|
Placebo
n=110 Participants
4 capsules of placebo
Placebo: Placebo once daily
|
|---|---|---|---|
|
Change From Baseline at Week 4 in ADHD Symptoms Measured With the ADHD Rating Scale Version IV With Adult Prompts (ADHD RS IV)
|
-12.38 units on a scale
Standard Error 1.07
|
-13.88 units on a scale
Standard Error 1.20
|
-9.7 units on a scale
Standard Error 1.07
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3Population: Intent to treat population
The ADHD RS-IV with adult prompts is an 18 item scale based on the DSM IV TR criteria for ADHD that provides a rating of the severity symptoms. Scoring is based on a 4 point Likert-type severity scale where 0 = none, 1 = mild, 2 = moderate, and 3 = severe. Clinicians scored the highest score that was generated for the prompts for each item. The ADHD rating scale total score is defined as sum of all 18 item scale scores (range 0 - 54).
Outcome measures
| Measure |
SEP-225289 4mg
n=116 Participants
SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses
SEP-225289: SEP-225289 4mg once daily
SEP-225289: SEP-225289 8mg once daily
|
SEP-225289 8mg
n=107 Participants
SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses
SEP-225289: SEP-225289 4mg once daily
SEP-225289: SEP-225289 8mg once daily
|
Placebo
n=110 Participants
4 capsules of placebo
Placebo: Placebo once daily
|
|---|---|---|---|
|
Change From Baseline in ADHD Symptoms Measured With the ADHD RS IV at Weeks 1, 2, 3.
Week 1
|
-7.46 units on a scale
Standard Error 0.77
|
-7.83 units on a scale
Standard Error 0.8
|
-7.88 units on a scale
Standard Error 0.79
|
|
Change From Baseline in ADHD Symptoms Measured With the ADHD RS IV at Weeks 1, 2, 3.
Week 2
|
-10.09 units on a scale
Standard Error 0.91
|
-11.03 units on a scale
Standard Error 0.97
|
-9.14 units on a scale
Standard Error 0.92
|
|
Change From Baseline in ADHD Symptoms Measured With the ADHD RS IV at Weeks 1, 2, 3.
Week 3
|
-12.16 units on a scale
Standard Error 0.99
|
-12.79 units on a scale
Standard Error 1.09
|
-9.62 units on a scale
Standard Error 1.0
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4Population: Intent to treat
The CGI-S modified asked the clinician one question: Considering your total clinical experience with adult ADHD, how mentally ill is the subject at this time?".The clinician's answer was rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = ng the most extremely ill subjects.
Outcome measures
| Measure |
SEP-225289 4mg
n=116 Participants
SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses
SEP-225289: SEP-225289 4mg once daily
SEP-225289: SEP-225289 8mg once daily
|
SEP-225289 8mg
n=107 Participants
SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses
SEP-225289: SEP-225289 4mg once daily
SEP-225289: SEP-225289 8mg once daily
|
Placebo
n=110 Participants
4 capsules of placebo
Placebo: Placebo once daily
|
|---|---|---|---|
|
Change From Baseline in Clinical Global Impression - Severity of Illness Scale (CGI S) at Weeks 1, 2, 3, 4.
Week 1
|
-0.44 units on a scale
Standard Error 0.066
|
-0.43 units on a scale
Standard Error 0.069
|
-0.45 units on a scale
Standard Error 0.067
|
|
Change From Baseline in Clinical Global Impression - Severity of Illness Scale (CGI S) at Weeks 1, 2, 3, 4.
Week 2
|
-0.74 units on a scale
Standard Error 0.085
|
-0.74 units on a scale
Standard Error 0.091
|
-0.61 units on a scale
Standard Error 0.086
|
|
Change From Baseline in Clinical Global Impression - Severity of Illness Scale (CGI S) at Weeks 1, 2, 3, 4.
Week 3
|
-0.98 units on a scale
Standard Error 0.091
|
-0.93 units on a scale
Standard Error 0.102
|
-0.69 units on a scale
Standard Error 0.092
|
|
Change From Baseline in Clinical Global Impression - Severity of Illness Scale (CGI S) at Weeks 1, 2, 3, 4.
Week 4
|
-1.08 units on a scale
Standard Error 0.103
|
-1.14 units on a scale
Standard Error 0.118
|
-0.74 units on a scale
Standard Error 0.103
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4Population: Intent to treat
The ADHD RS-IV with adult prompts is an 18 item scale based on the DSM IV TR criteria for ADHD that provides a rating of the severity symptoms. Scoring is based on a 4 point Likert-type severity scale where 0 = none, 1 = mild, 2 = moderate, and 3 = severe. Clinicians scored the highest score that was generated for the prompts for each item. The even number items (2, 4, 6, 8, 10, 12, 14, 16, 18) assess hyperactive impulsive symptoms and the odd number items (1, 3, 5, 7, 9, 11, 13, 15, 17) assess inattentive symptoms. The ADHD inattentiveness subscale score is defined as sum of items (1, 3, 5, 7, 9, 11, 13, 15, 17) scores (range 0 - 27). The ADHD hyperactive impulsive subscale score is defined as sum of items (2, 4, 6, 8, 10, 12, 14, 16, 18) scores (range 0 - 27).
Outcome measures
| Measure |
SEP-225289 4mg
n=116 Participants
SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses
SEP-225289: SEP-225289 4mg once daily
SEP-225289: SEP-225289 8mg once daily
|
SEP-225289 8mg
n=107 Participants
SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses
SEP-225289: SEP-225289 4mg once daily
SEP-225289: SEP-225289 8mg once daily
|
Placebo
n=110 Participants
4 capsules of placebo
Placebo: Placebo once daily
|
|---|---|---|---|
|
Change From Baseline in the Inattentiveness and Hyperactivity Subscales of the ADHD RS IV at Weeks 1, 2, 3, 4
inattentivenes Week 1
|
-4.23 units on a scale
Standard Error 0.465
|
-4.61 units on a scale
Standard Error 0.483
|
-4.64 units on a scale
Standard Error 0.474
|
|
Change From Baseline in the Inattentiveness and Hyperactivity Subscales of the ADHD RS IV at Weeks 1, 2, 3, 4
inattentivenes Week 2
|
-5.75 units on a scale
Standard Error 0.539
|
-6.32 units on a scale
Standard Error 0.581
|
-5.43 units on a scale
Standard Error 0.546
|
|
Change From Baseline in the Inattentiveness and Hyperactivity Subscales of the ADHD RS IV at Weeks 1, 2, 3, 4
inattentivenes Week 3
|
-6.93 units on a scale
Standard Error 0.60
|
-7.03 units on a scale
Standard Error 0.669
|
-5.89 units on a scale
Standard Error 0.606
|
|
Change From Baseline in the Inattentiveness and Hyperactivity Subscales of the ADHD RS IV at Weeks 1, 2, 3, 4
inattentivenes Week 4
|
-7.0 units on a scale
Standard Error 0.641
|
-7.97 units on a scale
Standard Error 0.732
|
-5.61 units on a scale
Standard Error 0.643
|
|
Change From Baseline in the Inattentiveness and Hyperactivity Subscales of the ADHD RS IV at Weeks 1, 2, 3, 4
hyperactivity Week 1
|
-3.23 units on a scale
Standard Error 0.391
|
-3.20 units on a scale
Standard Error 0.405
|
-3.26 units on a scale
Standard Error 0.399
|
|
Change From Baseline in the Inattentiveness and Hyperactivity Subscales of the ADHD RS IV at Weeks 1, 2, 3, 4
hyperactivity Week 2
|
-4.35 units on a scale
Standard Error 0.462
|
-4.71 units on a scale
Standard Error 0.498
|
-3.75 units on a scale
Standard Error 0.467
|
|
Change From Baseline in the Inattentiveness and Hyperactivity Subscales of the ADHD RS IV at Weeks 1, 2, 3, 4
hyperactivity Week 3
|
-5.23 units on a scale
Standard Error 0.496
|
-4.78 units on a scale
Standard Error 0.553
|
-3.78 units on a scale
Standard Error 0.501
|
|
Change From Baseline in the Inattentiveness and Hyperactivity Subscales of the ADHD RS IV at Weeks 1, 2, 3, 4
hyperactivity Week 4
|
-5.39 units on a scale
Standard Error 0.536
|
-5.94 units on a scale
Standard Error 0.615
|
-4.13 units on a scale
Standard Error 0.536
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4Population: Intent to treat
Outcome measures
| Measure |
SEP-225289 4mg
n=116 Participants
SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses
SEP-225289: SEP-225289 4mg once daily
SEP-225289: SEP-225289 8mg once daily
|
SEP-225289 8mg
n=107 Participants
SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses
SEP-225289: SEP-225289 4mg once daily
SEP-225289: SEP-225289 8mg once daily
|
Placebo
n=110 Participants
4 capsules of placebo
Placebo: Placebo once daily
|
|---|---|---|---|
|
The Number of Responders at Weeks 1, 2, 3, 4. A Responder is Defined as a Subject With a ≥ 30% Improvement in ADHD Symptoms Compared With Baseline as Measured by the ADHD RS IV.
Week 1
|
36 participants
|
35 participants
|
35 participants
|
|
The Number of Responders at Weeks 1, 2, 3, 4. A Responder is Defined as a Subject With a ≥ 30% Improvement in ADHD Symptoms Compared With Baseline as Measured by the ADHD RS IV.
Week 2
|
44 participants
|
39 participants
|
39 participants
|
|
The Number of Responders at Weeks 1, 2, 3, 4. A Responder is Defined as a Subject With a ≥ 30% Improvement in ADHD Symptoms Compared With Baseline as Measured by the ADHD RS IV.
Week 3
|
55 participants
|
43 participants
|
36 participants
|
|
The Number of Responders at Weeks 1, 2, 3, 4. A Responder is Defined as a Subject With a ≥ 30% Improvement in ADHD Symptoms Compared With Baseline as Measured by the ADHD RS IV.
Week 4
|
49 participants
|
38 participants
|
40 participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4Population: Intent to treat
The WRAADDS measured the severity of the target symptoms of adults with ADHD. It measured symptoms in 7 categories: attention difficulties, hyperactivity/restlessness, temper, affective lability, emotional overreactivity, disorganization, and impulsivity. The scale rated individual items from 0 to 2 (0 = not present, 1 = mild, 2 = clearly present) and summarized each of the 7 categories on a 0 to 4 scale (0 = none, 1 = mild, 2 = moderate, 3 = quite a bit, 4 = very much). The WRAADDS total score is defined as sum of all 28 item subscores (range 0 - 56).
Outcome measures
| Measure |
SEP-225289 4mg
n=116 Participants
SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses
SEP-225289: SEP-225289 4mg once daily
SEP-225289: SEP-225289 8mg once daily
|
SEP-225289 8mg
n=107 Participants
SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses
SEP-225289: SEP-225289 4mg once daily
SEP-225289: SEP-225289 8mg once daily
|
Placebo
n=110 Participants
4 capsules of placebo
Placebo: Placebo once daily
|
|---|---|---|---|
|
Change From Baseline in the Wender-Reimher Adult Attention Deficit Disorder Scale (WRAADDS) as Measured at Weeks 1, 2, 3, 4.
Week 1
|
-5.9 units on a scale
Standard Error 0.783
|
-6.97 units on a scale
Standard Error 0.813
|
-6.87 units on a scale
Standard Error 0.80
|
|
Change From Baseline in the Wender-Reimher Adult Attention Deficit Disorder Scale (WRAADDS) as Measured at Weeks 1, 2, 3, 4.
Week 2
|
-8.85 units on a scale
Standard Error 0.919
|
-9.11 units on a scale
Standard Error 0.992
|
-8.10 units on a scale
Standard Error 0.933
|
|
Change From Baseline in the Wender-Reimher Adult Attention Deficit Disorder Scale (WRAADDS) as Measured at Weeks 1, 2, 3, 4.
Week 3
|
-10.74 units on a scale
Standard Error 0.957
|
-9.84 units on a scale
Standard Error 1.07
|
-8.15 units on a scale
Standard Error 0.967
|
|
Change From Baseline in the Wender-Reimher Adult Attention Deficit Disorder Scale (WRAADDS) as Measured at Weeks 1, 2, 3, 4.
Week 4
|
-11.02 units on a scale
Standard Error 1.005
|
-11.91 units on a scale
Standard Error 1.166
|
-8.97 units on a scale
Standard Error 1.004
|
Adverse Events
SEP-225289 4mg
Serious events: 2 serious events
Other events: 88 other events
Deaths: 0 deaths
SEP-225289 8mg
Serious events: 1 serious events
Other events: 89 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 65 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SEP-225289 4mg
n=116 participants at risk
SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses
SEP-225289: SEP-225289 4mg once daily
SEP-225289: SEP-225289 8mg once daily
|
SEP-225289 8mg
n=111 participants at risk
SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses
SEP-225289: SEP-225289 4mg once daily
SEP-225289: SEP-225289 8mg once daily
|
Placebo
n=110 participants at risk
4 capsules of placebo
Placebo: Placebo once daily
|
|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.86%
1/116 • Number of events 1 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
0.00%
0/111 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
0.00%
0/110 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
|
Psychiatric disorders
Psychotic disorder
|
0.86%
1/116 • Number of events 1 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
0.00%
0/111 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
0.00%
0/110 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
|
Infections and infestations
Mediastinitis
|
0.00%
0/116 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
0.90%
1/111 • Number of events 1 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
0.00%
0/110 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
|
Infections and infestations
Staphylococcal bacteraemi
|
0.00%
0/116 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
0.90%
1/111 • Number of events 1 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
0.00%
0/110 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
Other adverse events
| Measure |
SEP-225289 4mg
n=116 participants at risk
SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses
SEP-225289: SEP-225289 4mg once daily
SEP-225289: SEP-225289 8mg once daily
|
SEP-225289 8mg
n=111 participants at risk
SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses
SEP-225289: SEP-225289 4mg once daily
SEP-225289: SEP-225289 8mg once daily
|
Placebo
n=110 participants at risk
4 capsules of placebo
Placebo: Placebo once daily
|
|---|---|---|---|
|
Psychiatric disorders
Combined insomniaa
|
34.5%
40/116 • Number of events 45 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
45.0%
50/111 • Number of events 55 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
15.5%
17/110 • Number of events 18 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
|
Psychiatric disorders
Insomnia
|
25.0%
29/116 • Number of events 32 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
36.9%
41/111 • Number of events 46 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
10.0%
11/110 • Number of events 12 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
|
Psychiatric disorders
Anxiety
|
9.5%
11/116 • Number of events 11 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
9.0%
10/111 • Number of events 11 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
1.8%
2/110 • Number of events 2 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
|
Psychiatric disorders
Initial insomnia
|
3.4%
4/116 • Number of events 5 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
5.4%
6/111 • Number of events 6 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
2.7%
3/110 • Number of events 3 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
|
Psychiatric disorders
Middle insomnia
|
3.4%
4/116 • Number of events 4 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
4.5%
5/111 • Number of events 5 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
1.8%
2/110 • Number of events 2 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
|
Psychiatric disorders
Depressed mood
|
3.4%
4/116 • Number of events 4 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
0.90%
1/111 • Number of events 1 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
0.00%
0/110 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
|
Psychiatric disorders
Abnormal dreams
|
1.7%
2/116 • Number of events 2 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
1.8%
2/111 • Number of events 2 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
4.5%
5/110 • Number of events 5 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/116 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
3.6%
4/111 • Number of events 4 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
0.91%
1/110 • Number of events 1 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
|
Nervous system disorders
Headache
|
12.9%
15/116 • Number of events 19 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
10.8%
12/111 • Number of events 12 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
10.9%
12/110 • Number of events 16 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
|
Nervous system disorders
Dizziness
|
6.9%
8/116 • Number of events 8 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
8.1%
9/111 • Number of events 9 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
0.91%
1/110 • Number of events 1 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
|
Nervous system disorders
Tension headache
|
5.2%
6/116 • Number of events 6 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
0.00%
0/111 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
0.00%
0/110 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
|
Nervous system disorders
Somnolence
|
1.7%
2/116 • Number of events 2 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
0.90%
1/111 • Number of events 1 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
3.6%
4/110 • Number of events 4 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
|
Gastrointestinal disorders
Dry mouth
|
7.8%
9/116 • Number of events 9 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
17.1%
19/111 • Number of events 19 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
2.7%
3/110 • Number of events 3 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
|
Gastrointestinal disorders
Nausea
|
6.0%
7/116 • Number of events 7 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
9.9%
11/111 • Number of events 11 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
2.7%
3/110 • Number of events 6 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
|
General disorders
Irritability
|
8.6%
10/116 • Number of events 10 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
9.0%
10/111 • Number of events 10 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
8.2%
9/110 • Number of events 9 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
|
Gastrointestinal disorders
Fatigue
|
6.0%
7/116 • Number of events 9 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
7.2%
8/111 • Number of events 8 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
4.5%
5/110 • Number of events 5 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.3%
12/116 • Number of events 12 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
22.5%
25/111 • Number of events 26 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
2.7%
3/110 • Number of events 3 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
|
Infections and infestations
Upper respiratory tract infection
|
4.3%
5/116 • Number of events 5 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
2.7%
3/111 • Number of events 3 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
5.5%
6/110 • Number of events 6 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
|
Infections and infestations
Nasopharyngitis
|
3.4%
4/116 • Number of events 4 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
1.8%
2/111 • Number of events 2 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
2.7%
3/110 • Number of events 3 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.6%
3/116 • Number of events 3 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
3.6%
4/111 • Number of events 4 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
2.7%
3/110 • Number of events 3 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
|
Investigations
Weight decreased
|
2.6%
3/116 • Number of events 4 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
5.4%
6/111 • Number of events 6 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
0.91%
1/110 • Number of events 1 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
|
Cardiac disorders
Palpitations
|
5.2%
6/116 • Number of events 6 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
2.7%
3/111 • Number of events 3 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
0.00%
0/110 • From baseline to week 4 for double-blind treatment, then 2 weeks of follow-up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee There IS agreement between Principal Investigator and Sponsor that restricts PI's rights to discuss or publish trial results after trial is completed. In addition to the \<60-180 day restriction above, since this is a multicenter study, 1st publication of study results shall be made with other participating study sites as a multicenter publication provided, if a multicenter publication is not forthcoming within 24 months post completion of study at all sites, PI shall be free to publish.
- Publication restrictions are in place
Restriction type: OTHER