Trial Outcomes & Findings for Atomoxetine for Treatment of Weight Gain in Olanzapine or Clozapine Patients (NCT NCT00176436)
NCT ID: NCT00176436
Last Updated: 2022-03-14
Results Overview
Weight loss was measured each week over the 24 week study period. Intent to treat analyses of treatment effects on the primary outcome (weight) were conducted using all observed weight measurements from all participants with post-baseline weight measurements, using the mixed model for unbalanced repeated measures ANOVA. This model summarizes change in weight for each participant by the average change in weight per week (slope) over 24 weeks, and compares these slopes between the two groups.
COMPLETED
PHASE4
40 participants
Weekly for 24 weeks
2022-03-14
Participant Flow
Recruitment took place from 2004 until March, 2008. Participants were recruited from the Maryland Psychiatric Research Center Outpatient Research Program and local community mental health centers.
There was a 2-week evaluation period during which time a diet and exercise program was implemented. All participants then began the double-blind treatment phase of the study. No participants were excluded unless the were taking an excluded medication. 40 participants were enrolled into active participation; 37 participants started treatment.
Participant milestones
| Measure |
Active
Atomoxetine titrated up to 120 mg/day by week 8 and continues at 120 mg/day through week 24.
|
Placebo
Placebo medication, diet support group weekly and exercise sessions 3 times/week
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
17
|
|
Overall Study
COMPLETED
|
14
|
12
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Atomoxetine for Treatment of Weight Gain in Olanzapine or Clozapine Patients
Baseline characteristics by cohort
| Measure |
Active
n=20 Participants
Atomoxetine titrated up to 120 mg/day by week 8 and continues at 120 mg/day through week 24.
|
Placebo
n=17 Participants
Placebo medication, diet support group weekly and exercise sessions 3 times/week
|
Total
n=37 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
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
47.8 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
46.1 years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
46.9 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
17 participants
n=7 Participants
|
37 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weekly for 24 weeksWeight loss was measured each week over the 24 week study period. Intent to treat analyses of treatment effects on the primary outcome (weight) were conducted using all observed weight measurements from all participants with post-baseline weight measurements, using the mixed model for unbalanced repeated measures ANOVA. This model summarizes change in weight for each participant by the average change in weight per week (slope) over 24 weeks, and compares these slopes between the two groups.
Outcome measures
| Measure |
Active
n=20 Participants
Atomoxetine titrated up to 120 mg/day by week 8 and continues at 120 mg/day through week 24.
|
Placebo
n=17 Participants
Placebo medication, diet support group weekly and exercise sessions 3 times/week
|
|---|---|---|
|
Change From Baseline in Weight
|
1.7 kilograms
Standard Deviation 1.4
|
2.1 kilograms
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 24 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Weekly for 24 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, 10 weeks and 24 weeksOutcome measures
Outcome data not reported
Adverse Events
Active
Placebo
Serious adverse events
| Measure |
Active
Atomoxetine titrated up to 120 mg/day by week 8 and continues at 120 mg/day through week 24.
|
Placebo
Placebo medication, diet support group weekly and exercise sessions 3 times/week
|
|---|---|---|
|
Cardiac disorders
Hypotension
|
5.0%
1/20 • 6 months
Weekly questionnaire assessing potential side effects
|
0.00%
0/17 • 6 months
Weekly questionnaire assessing potential side effects
|
|
General disorders
Extreme Sedation
|
5.0%
1/20 • 6 months
Weekly questionnaire assessing potential side effects
|
0.00%
0/17 • 6 months
Weekly questionnaire assessing potential side effects
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/20 • 6 months
Weekly questionnaire assessing potential side effects
|
5.9%
1/17 • 6 months
Weekly questionnaire assessing potential side effects
|
Other adverse events
| Measure |
Active
Atomoxetine titrated up to 120 mg/day by week 8 and continues at 120 mg/day through week 24.
|
Placebo
Placebo medication, diet support group weekly and exercise sessions 3 times/week
|
|---|---|---|
|
Vascular disorders
Dizziness
|
5.0%
1/20 • 6 months
Weekly questionnaire assessing potential side effects
|
0.00%
0/17 • 6 months
Weekly questionnaire assessing potential side effects
|
|
Nervous system disorders
Slurred speech
|
5.0%
1/20 • 6 months
Weekly questionnaire assessing potential side effects
|
0.00%
0/17 • 6 months
Weekly questionnaire assessing potential side effects
|
|
Cardiac disorders
Abnormal ECG
|
5.0%
1/20 • 6 months
Weekly questionnaire assessing potential side effects
|
0.00%
0/17 • 6 months
Weekly questionnaire assessing potential side effects
|
|
Cardiac disorders
Hypotension
|
5.0%
1/20 • 6 months
Weekly questionnaire assessing potential side effects
|
0.00%
0/17 • 6 months
Weekly questionnaire assessing potential side effects
|
|
Psychiatric disorders
Nervousness
|
5.0%
1/20 • 6 months
Weekly questionnaire assessing potential side effects
|
0.00%
0/17 • 6 months
Weekly questionnaire assessing potential side effects
|
|
Cardiac disorders
Hypertension
|
0.00%
0/20 • 6 months
Weekly questionnaire assessing potential side effects
|
5.9%
1/17 • 6 months
Weekly questionnaire assessing potential side effects
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/20 • 6 months
Weekly questionnaire assessing potential side effects
|
5.9%
1/17 • 6 months
Weekly questionnaire assessing potential side effects
|
|
Blood and lymphatic system disorders
Abnormal SGOT and SGPT
|
0.00%
0/20 • 6 months
Weekly questionnaire assessing potential side effects
|
5.9%
1/17 • 6 months
Weekly questionnaire assessing potential side effects
|
Additional Information
M. Patricia Ball, R.N., C.,M.S.
Maryland Psychiatric Research Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place