Status:
COMPLETED
Short Term Rescue Study of Olanzapine
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Bipolar Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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 t...
Detailed Description
Development and marketing of new therapies for bipolar disorders (BD) has typically entailed performing double-blind placebo-controlled trials in acute mania maintenance studies and more recently acut...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00186017
Start Date
July 1 2005
End Date
June 1 2010
Last Update
May 16 2017
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305