Bipolar Depression Study: Bipolar Depression Assessment Study on Treatment Response
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| ClinicalTrials.gov Identifier: NCT00191399 |
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Recruitment Status :
Completed
First Posted : September 19, 2005
Last Update Posted : January 26, 2007
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Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
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Brief Summary:
The primary objective of this study is to assess the efficacy of olanzapine and fluoxetine combined on all the visits as compared with the baseline visit in patients with bipolar disorder, measured by the total score of the Montgomery-Asberg Depression Rating Scale (MADRS).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Depression, Bipolar | Drug: Olanzapine Drug: Fluoxetine | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 150 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Bipolar Depression Assessment Study on Tx Response |
| Study Start Date : | May 2004 |
| Study Completion Date : | March 2006 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Depression
Primary Outcome Measures :
- MADRS is a rating scale for severity of depressive mood symptoms.
Secondary Outcome Measures :
- Clinical Global Impression - Bipolar Version (CGI-BP) Severity - Depression is used by the clinician to record the severity of depression illness at the time of assessment
- CGI-BP Severity - Mania is used by the clinician to record the severity of mania illness at the time of assessment
- Short Form-12 (SF-12) Questionnaire was developed from the SF-36 Health Survey for use in monitoring outcomes for general and specific populations.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Meet criteria for bipolar depression, in the opinion of the investigator, according to the Diagnostic and Statistical Manual of Mental Disorders [Text Revision] (DSM-IV-TR) disease diagnostic criteria.
- Patients must have experienced, in the opinion of the investigator, at least one previous hypomanic, manic or mixed episode as defined in DSM-IV-TR.
- Subjects must have an initial score at Visit 1 of at least 20 on the MADRS.
Exclusion Criteria:
- Any patient currently meeting DSM-IV-TR criteria rapid-cycling course.
- A CGI-Severity - Mania score of at least 3.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00191399
Locations
| United States, Washington | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Seattle, Washington, United States | |
| Puerto Rico | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician | |
| Bayamon, Puerto Rico, 00956 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician | |
| Caguas, Puerto Rico, 725 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician | |
| Canovanas, Puerto Rico | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Hato Rey, Puerto Rico, 00936 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician | |
| Manati, Puerto Rico, 00674 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician | |
| Mayaguez, Puerto Rico, 00680 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician | |
| Rio Piedras, Puerto Rico | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician | |
| San Juan, Puerto Rico | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician | |
| Santurce, Puerto Rico | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Chair: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00191399 |
| Other Study ID Numbers: |
9370 F1D-SU-HGMA |
| First Posted: | September 19, 2005 Key Record Dates |
| Last Update Posted: | January 26, 2007 |
| Last Verified: | January 2007 |
Additional relevant MeSH terms:
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Depression Depressive Disorder Bipolar Disorder Behavioral Symptoms Mood Disorders Mental Disorders Bipolar and Related Disorders Olanzapine Fluoxetine Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Antipsychotic Agents |
Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Antidepressive Agents, Second-Generation Antidepressive Agents Cytochrome P-450 CYP2D6 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors |