Trial Outcomes & Findings for Combination of Paroxetine CR and Quetiapine for the Treatment of Refractory Generalized Anxiety Disorder (NCT NCT00113295)
NCT ID: NCT00113295
Last Updated: 2014-04-23
Results Overview
Symptoms of generalized anxiety disorder as measured by the Hamilton Anxiety Scale (HAM-A) at week 18/study endpoint. Each item is scored on a scale from 0 (not present) to 4 (severe) with a total score range of 0-56. Changes in HAM-A scores are calculated as the difference between the baseline HAM-A scores and scores at week 18/study endpoint. The 14-item Hamilton Anxiety Rating Scale (HAM-A) (Hamilton, 1959) was developed to assess anxiety in a clinical population. It is considered a measure of general anxiety across anxiety disorders, in addition to being a gold standard measure for GAD.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
50 participants
Primary outcome timeframe
Baseline and Week 18
Results posted on
2014-04-23
Participant Flow
One hundred and one individuals were recruited through advertisement and clinical referral from February 2004 to June 2007, signed consent, and participated in a screening visit. Fifty-four individuals (53.5%) with GAD met the study entry criteria and initiated paroxetine CR in phase 1 of the trial.
Seven patients did not complete phase 1. Of phase 1 completers, 21 were not randomized. Twenty-two patients were randomized, 11 to quetiapine and 11 to placebo augmentation. \*Note that the data reported throughout the results section are from Phase 2 only.
Participant milestones
| Measure |
Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine
In the first phase of the study, individuals started at 12.5 mg/day of paroxetine and flexibly tirated up to a maximum of 62.5 mg/day by week 10. Individuals who did not receive remission and were randomized to receive quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16.
|
Placebo Augmentation of Continued Paroxetine
In the first phase of the study, individuals started at 12.5 mg/day of paroxetine and flexibly titrated up to a maximum of 62.5 mg/day by week 10. Individuals who did not achieve remission and were randomized into the placebo group received placebo augmentation of continued paroxetine CR at the week 10 dose level.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
6
|
10
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
Reasons for withdrawal
| Measure |
Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine
In the first phase of the study, individuals started at 12.5 mg/day of paroxetine and flexibly tirated up to a maximum of 62.5 mg/day by week 10. Individuals who did not receive remission and were randomized to receive quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16.
|
Placebo Augmentation of Continued Paroxetine
In the first phase of the study, individuals started at 12.5 mg/day of paroxetine and flexibly titrated up to a maximum of 62.5 mg/day by week 10. Individuals who did not achieve remission and were randomized into the placebo group received placebo augmentation of continued paroxetine CR at the week 10 dose level.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
1
|
|
Overall Study
Unrelated Medical Illness
|
1
|
0
|
Baseline Characteristics
Combination of Paroxetine CR and Quetiapine for the Treatment of Refractory Generalized Anxiety Disorder
Baseline characteristics by cohort
| Measure |
Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine
n=11 Participants
Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16.
|
Placebo Augmentation of Continued Paroxetine
n=11 Participants
Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
At Phase 2 Baseline
|
43.8 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
40.5 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
42.2 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex/Gender, Customized
Phase 2 Baseline Females
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Sex/Gender, Customized
Phase 2 Baseline Males
|
7 participants
n=5 Participants
|
4 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
HAM-A
|
16.27 units on a scale
STANDARD_DEVIATION 5.04 • n=5 Participants
|
15.82 units on a scale
STANDARD_DEVIATION 4.77 • n=7 Participants
|
16.05 units on a scale
STANDARD_DEVIATION 4.8 • n=5 Participants
|
|
CGI-S
|
3.64 Units on a scale
STANDARD_DEVIATION 0.67 • n=5 Participants
|
3.91 Units on a scale
STANDARD_DEVIATION 0.83 • n=7 Participants
|
3.77 Units on a scale
STANDARD_DEVIATION 0.75 • n=5 Participants
|
|
MADRS
|
11.45 units on a scale
STANDARD_DEVIATION 1.93 • n=5 Participants
|
12.36 units on a scale
STANDARD_DEVIATION 4.80 • n=7 Participants
|
11.91 units on a scale
STANDARD_DEVIATION 3.66 • n=5 Participants
|
|
Q-LES-Q
|
45.13 units on a scale
STANDARD_DEVIATION 10.6 • n=5 Participants
|
45.89 units on a scale
STANDARD_DEVIATION 8.88 • n=7 Participants
|
45.51 units on a scale
STANDARD_DEVIATION 9.77 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 18Population: Twenty-two patients were randomized, 11 to quetiapine and 11 to placebo augmentation, and all had at least one assessment postrandomization and were included in the phase 2 efficacy analyses; of this group, six randomized to quetiapine (54.5%) and ten to placebo (90.1%) completed the trial.
Symptoms of generalized anxiety disorder as measured by the Hamilton Anxiety Scale (HAM-A) at week 18/study endpoint. Each item is scored on a scale from 0 (not present) to 4 (severe) with a total score range of 0-56. Changes in HAM-A scores are calculated as the difference between the baseline HAM-A scores and scores at week 18/study endpoint. The 14-item Hamilton Anxiety Rating Scale (HAM-A) (Hamilton, 1959) was developed to assess anxiety in a clinical population. It is considered a measure of general anxiety across anxiety disorders, in addition to being a gold standard measure for GAD.
Outcome measures
| Measure |
Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine
n=11 Participants
Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16.
|
Placebo Augmentation of Continued Paroxetine
n=11 Participants
Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level.
|
|---|---|---|
|
Hamilton Anxiety Scale (HAM-A) Score at Study Endpoint.
Baseline
|
16.27 units on a scale
Standard Deviation 5.04
|
15.82 units on a scale
Standard Deviation 4.77
|
|
Hamilton Anxiety Scale (HAM-A) Score at Study Endpoint.
Week 18
|
13.64 units on a scale
Standard Deviation 8.36
|
15.55 units on a scale
Standard Deviation 7.97
|
|
Hamilton Anxiety Scale (HAM-A) Score at Study Endpoint.
Change
|
-2.6 units on a scale
Standard Deviation 5.8
|
-0.3 units on a scale
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: Week 18 (Study Endpoint)Remission was measured as a secondary outcome using a score of less than or equal to 7 on the Hamilton Anxiety Scale (HAM-A).
Outcome measures
| Measure |
Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine
n=11 Participants
Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16.
|
Placebo Augmentation of Continued Paroxetine
n=11 Participants
Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level.
|
|---|---|---|
|
Remission (HAM-A ≤ 7)
|
4 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Week 18 (Phase 2 Endpoint)Response was measured as a secondary outcome using the Clinical Global Impression of Improvement (CGI-I). Response was defined as a score of 1 \["very much improved"\] or 2 \["much improved"\] at study endpoint.
Outcome measures
| Measure |
Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine
n=11 Participants
Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16.
|
Placebo Augmentation of Continued Paroxetine
n=11 Participants
Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level.
|
|---|---|---|
|
Response, Clinical Global Impression of Improvement (CGI-I)
|
6 participants
0.8
|
5 participants
0.8
|
SECONDARY outcome
Timeframe: Week 10 (Phase 1 Endpoint) and Week 18 (Phase 2 Endpoint)Depressive symptoms were measured at a secondary outcome using the Montgomery-Asberg Depression Rating Scale (MADRS). Each item is scored on a scale of 1-6; The total score range is 0-60, with higher scores indicated higher levels of depression severity.
Outcome measures
| Measure |
Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine
n=11 Participants
Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16.
|
Placebo Augmentation of Continued Paroxetine
n=11 Participants
Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level.
|
|---|---|---|
|
Depressive Symptoms, Montgomery-Asberg Depression Rating Scale (MADRS)
Baseline (Week 10)
|
11.45 units on a scale
Standard Deviation 1.93
|
12.36 units on a scale
Standard Deviation 4.80
|
|
Depressive Symptoms, Montgomery-Asberg Depression Rating Scale (MADRS)
Endpoint (Week 18)
|
10.27 units on a scale
Standard Deviation 7.30
|
11.64 units on a scale
Standard Deviation 5.92
|
SECONDARY outcome
Timeframe: Week 10 (Phase 1 Endpoint) and Week 18 (Phase 2 Endpoint)The 16-item Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) is used to assess quality of life changes with treatment. Total scores range from 14-70, with higher levels of satisfaction yielding higher scores.
Outcome measures
| Measure |
Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine
n=11 Participants
Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16.
|
Placebo Augmentation of Continued Paroxetine
n=11 Participants
Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level.
|
|---|---|---|
|
The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q).
Baseline (Week 10)
|
45.13 units on a scale
Standard Deviation 10.64
|
45.89 units on a scale
Standard Deviation 8.88
|
|
The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q).
Endpoint (Week 18)
|
46.25 units on a scale
Standard Deviation 9.45
|
45.11 units on a scale
Standard Deviation 10.55
|
Adverse Events
Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo Augmentation of Continued Paroxetine
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Paroxetine
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine
n=11 participants at risk
Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16.
|
Placebo Augmentation of Continued Paroxetine
n=11 participants at risk
Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level.
|
Paroxetine
n=50 participants at risk
Individuals received paroxetine CR for 10 weeks in Phase 1 of the study, initiated at 12.5 mg and flexibly titrated up to a maximum of 62.5 mg/day by week 8.
|
|---|---|---|---|
|
General disorders
Migraine Headache
|
9.1%
1/11 • Number of events 1 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/50 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
|
General disorders
Nausea and high fever
|
9.1%
1/11 • Number of events 1 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/50 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
9.1%
1/11 • Number of events 1 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/50 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
Other adverse events
| Measure |
Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine
n=11 participants at risk
Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16.
|
Placebo Augmentation of Continued Paroxetine
n=11 participants at risk
Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level.
|
Paroxetine
n=50 participants at risk
Individuals received paroxetine CR for 10 weeks in Phase 1 of the study, initiated at 12.5 mg and flexibly titrated up to a maximum of 62.5 mg/day by week 8.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Appetite Decrease
|
9.1%
1/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/50 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
|
Gastrointestinal disorders
Constipation
|
9.1%
1/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
18.2%
2/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
2.0%
1/50 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
|
Gastrointestinal disorders
Diarrhea
|
27.3%
3/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
18.2%
2/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/50 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
|
General disorders
Dry mouth
|
27.3%
3/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/50 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
|
General disorders
Fatigue
|
0.00%
0/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
9.1%
1/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
10.0%
5/50 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
|
General disorders
Headaches
|
9.1%
1/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
9.1%
1/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
2.0%
1/50 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
|
General disorders
Insomnia
|
9.1%
1/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
27.3%
3/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/50 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
|
General disorders
Jittery/shaky/restless
|
9.1%
1/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/50 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
|
General disorders
Nausea
|
9.1%
1/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/50 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
|
General disorders
Sedation
|
54.5%
6/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
9.1%
1/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/50 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
|
General disorders
Sexual dysfunction
|
18.2%
2/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
27.3%
3/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/50 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
|
General disorders
Trouble Sleeping
|
9.1%
1/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
2.0%
1/50 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
|
Renal and urinary disorders
Urinary hesitancy
|
9.1%
1/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/50 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
|
General disorders
Vivid Dreams
|
9.1%
1/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
27.3%
3/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/50 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
|
Metabolism and nutrition disorders
Weight gain
|
0.00%
0/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
18.2%
2/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/50 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
|
General disorders
Akathisia
|
9.1%
1/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/50 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
|
General disorders
Difficulty Concentrating
|
9.1%
1/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
9.1%
1/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/50 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
|
General disorders
Forgetfulness
|
9.1%
1/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/50 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.1%
1/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
9.1%
1/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/50 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
|
Gastrointestinal disorders
Gas
|
9.1%
1/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/50 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
|
General disorders
Irritability
|
9.1%
1/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/50 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
|
General disorders
Myoclonic Jerks
|
9.1%
1/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/50 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
|
General disorders
Morning Grogginess
|
9.1%
1/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/50 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
|
General disorders
Spasm
|
9.1%
1/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
9.1%
1/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/50 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
|
General disorders
Appetite Increase
|
9.1%
1/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/50 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
|
General disorders
Tremor
|
9.1%
1/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/50 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
|
General disorders
Increased Sleep
|
0.00%
0/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
9.1%
1/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/50 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
|
General disorders
Sweating
|
0.00%
0/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
18.2%
2/11 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
0.00%
0/50 • Adverse Event data was collected throughout the 18 week study period, both during Phase 1 (ten weeks) and Phase 2 (eight weeks).
Safety evaluation included assessment of vital signs and weight at each visit and open-ended query regarding adverse events. The Simpson-Angus Scale (Simpson and Angus 1970) and the Barnes Akathisia Scale (Barnes 1989) were employed to assess for the development of akathisia and extrapyramidal side effects.
|
Additional Information
Naomi M. Simon, M.D., M.Sc.
Massachusetts General Hospital
Phone: (617) 726-7913
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place