Phase 4
Completed N=37
Atomoxetine for Treatment of Weight Gain in Olanzapine or Clozapine Patients
Source: ClinicalTrials.gov NCT00176436 ↗Enrolled (actual)
37
Serious AEs
—
Results posted
Jun 2013
Primary outcomePrimary: Change From Baseline in Weight — 1.7; 2.1 kilograms
Summary
The study investigates the use of Atomoxetine in combination with exercise and a diet support group (Weight Watchers)to treat weight gain associated with Olanzapine or clozapine. All patients must be adults who have been diagnosed with Schizophrenia or Schizoaffective Disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Weight |
1.7; 2.1 | — |
| SECONDARY Secondary Outcomes Are Improvement in Cognitive Impairments, Since Atomoxetine is Used for Treatment of ADHD and is Known to Improve Cognitive Function. |
— | — |
| SECONDARY Vital Signs |
— | — |
| SECONDARY Chemistry Panel |
— | — |
Eligibility Criteria
Inclusion Criteria
- Schizophrenia or schizoaffective Disorder
- Taking olanzapine or clozapine for at least 6 months
- Weight gain of 7% over baseline or BMI greater than or equal to 27
Exclusion Criteria
- Current treatment with methylphenidate, clonidine, tricyclic antidepressants, bupropion and venlafaxine
- Treatment with other medications known to cause weight gain unless weight stable on medication for 6 months
- Current treatment with other medications for weight loss unless weight stable for 6 months
- Mental Retardation
- Alcohol or Substance Dependence within the last 6 months
- Pregnancy
- Alcohol or Substance Abuse within the lat month
- Uncontrolled hypertension defined as a blood pressure exceeding 140/90 on three consecutive readings despite adequate treatment
Data sourced from ClinicalTrials.gov (NCT00176436). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.