Phase 4
N=23
Medication, Weight Gain and GI Hormones
Bipolar Depression
Bottom Line
View on ClinicalTrials.gov: NCT00384332 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Weight in Kilograms at Baseline, Weeks 1, 4, 6, and 8 — 76.0; 76.1; 77.4; 77.6 kilograms
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- orally-disintegrating olanzapine (Drug); regular olanzapine (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight in Kilograms at Baseline, Weeks 1, 4, 6, and 8 |
76.0; 76.1; 77.4; 77.6; 77.8; 78.3 | — |
| SECONDARY Change From Baseline Montgomery Asberg Depression Rating Scale |
-15.5; -15.5 | — |
Summary
This is an 8 week study that compares two medications. One medication is olanzapine (5-20 mg daily) whereas the other medication is an orally disintegrating medication. Both medications are used to treat depressed bipolar patients. The main focus of this study is the comparison of these two medications on gastro-intestinal hormones and weight gain.
Eligibility Criteria
Inclusion Criteria
- A principal diagnosis of bipolar 1 or II disorder
- Ages 18-60
- Physically healthy
- Outpatient status
- Montgomery-Asberg Rating Scale (MADRS) Score greater than or equal to 15
- BMI 23-30
- Able and willing to give written informed consent
Exclusion Criteria
- Prior history of diabetes (types I or II)
- BMI>30
- Non-fasting blood glucose >124
- Fasting blood glucose >125 or random blood glucose >200
- Presence of dyslipidemia (baseline total cholesterol >240, HDL 160, triglycerides >199)
- Current or past history of a non-affective psychotic disorder
- Alcohol or other substance abuse or dependence in the 6 months prior to the evaluation (except for caffeine)
- Current use of any nicotine products
- Schizoid, schizotypal, or borderline personality disorder
- Treatment with olanzapine in the prior 3 months or any history of non- response to or intolerance of olanzapine or the olanzapine-fluoxetine combination (SymbiaxTM)
- Suicide potential that, in the opinion of the investigator, precludes outpatient treatment or participation in a trial
- Participation of subjects in another drug trial within 30 days of evaluation
- The presence of any current medical condition judged by the investigator to potentially interfere with the study procedures or measures
- The likelihood of requiring hospitalization over the period of the study
- The presence of any clinically-significant laboratory abnormality as judged by the investigator
- Pregnancy or lactation
- History of seizure disorder, excluding febrile seizures of childhood
- Any disorder of taste or smell, including severe nasal allergies
- Any other condition which, in the investigator's judgment might increase the risk to the subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the study
- Being unable to comprehend or follow the study procedures.
Data sourced from ClinicalTrials.gov (NCT00384332). 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.