Phase 4
N=50
Short Term Rescue Study of Olanzapine
Bipolar Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00186017 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Mean Change in CGI-BP-OS After 1 Week of Treatment — -1.4; .8 units on a scale — p=.08
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Olanzapine/Zyprexa (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in CGI-BP-OS After 1 Week of Treatment |
-1.4; .8 | .08 |
| SECONDARY Mean Change in YMRS After 1 Week of Treatment |
-6.0; -3.3 | >.1 |
| SECONDARY Mean Change in MADRS After 1 Week of Treatment. |
-12.3; -6.8 | >.1 |
| SECONDARY Mean Change in Hamilton Anxiety Rating Scales (HAM-A) |
-7.9; -3.8 | — |
Summary
We will assess the effect of olanzapine compared to placebo added to prior treatment on CGI-S in a one-week randomized double-blind study. We will also assess the effect of olanzapine added to prior treatment on CGI-S in an eight-week open treatment study. In addition, we will assess the effect of olanzapine on Young Mania Rating Scale (YMRS), Hamilton and Montgomery-Asberg Depression Rating Scales (HDRS, and MADRS), and Hamilton Anxiety Rating Scales (HARS) in the above paradigms. We will also assess the influence of presentation severity (CGI-S) and polarity (mood elevation versus depression) on olanzapine response. Finally, we will assess safety and tolerability of olanzapine in the above paradigms.
We hypothesize that in diverse mild syndromal and subsyndromal exacerbations of BD in outpatients, randomized double-blind flexibly dosed olanzapine added to prior treatment (including no treatment) will yield greater CGI-S improvement than placebo by the end of one week, and that such improvement will persist over one week of open continuation treatment.
Eligibility Criteria
Inclusion Criteria:Patients must meet the following criteria to be eligible to participate in the study:
- Male or female outpatients, 18 to 70 years of age
- Female patients of childbearing potential must be using a medically accepted means of contraception
- Able to communicate intelligently with the investigator, and study coordinator
- Able to give informed consent
- DSM-IV diagnosis of bipolar I, bipolar II, cyclothymic disorder or bipolar disorder not otherwise specified, experiencing an acute exacerbation of their illness at Visit 1 (hypomania, subsyndromal depression, hypomania and subsyndromal depression, depression and hypomania, or depression if diagnosed with bipolar II) as verified by SCID-I/P
- CGI-BP Overall Severity score greater than or equal to mildly ill at Visit 1
- Must have been on prior medications for at least 2 weeks (6 weeks for fluoxetine) immediately prior to study entry Exclusion Criteria:Patients may not participate in the study if they have any of the following conditions:
- Pregnant, nursing, or intending to become pregnant during the study
- Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease such that hospitalization for the disease is anticipated within 3 months or death is anticipated within 3 years.
- A history of seizure disorder
- History of leukopenia without a clear and resolved etiology.
- DSM-IV substance (except nicotine or caffeine) dependence within the past month
- Judged clinically to be at serious suicidal risk
- Participation in clinical trial of another investigational drug within 1 month (30 days) prior to study entry.
- Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections prior to study entry
- Treatment resistance, non-response, or intolerability with olanzapine by the investigator's judgment
- Treatment with clozapine within 3 months prior to study entry
- Treatment with remoxipride within 6 months (180 days) prior to study entry
- Treatment with an oral antipsychotic within 2 days prior to study entry
- A course of ECT (electroconvulsive therapy) in the preceding 4 weeks
- Excluded mood symptoms noted in Table 1 [of protocol]
- Unstable thyroid pathology and treatment-initiated or altered within the past 3 months
- Meet criteria for antisocial personality disorder
Data sourced from ClinicalTrials.gov (NCT00186017). 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.