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| ID | Type | Description | Link |
|---|---|---|---|
| H6P-US-HDAQ |
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The purpose of this study is to assess olanzapine/fluoxetine combination and lamotrigine comparative efficacy, safety and tolerability in acute and longer term treatment of bipolar depression.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olanzapine | Drug | |||
| Fluoxetine | Drug | |||
| Lamotrigine | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the efficacy of olanzapine/fluoxetine combination compared with lamotrigine in the treatment of patients with bipolar I depression during the first 7 weeks of therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the efficacy of olanzapine/fluoxetine combination compared with lamotrigine on depressive symptoms | ||
| Assess the onset of action of olanzapine/fluoxetine combination compared with lamotrigine as measured by time to achieve an initial response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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. | Lafayette | Indiana |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21095016 | Derived | Houston J, Dharia S, Bishop JR, Ellingrod VL, Fijal B, Jacobson JG, Hoffmann VP. Association of DRD2 and ANKK1 polymorphisms with prolactin increase in olanzapine-treated women. Psychiatry Res. 2011 May 15;187(1-2):74-9. doi: 10.1016/j.psychres.2010.10.020. Epub 2010 Nov 20. |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077152 | Olanzapine |
| D005473 | Fluoxetine |
| D000077213 | Lamotrigine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Assess the study-defined response and remission rates including time to achieve a full response and time to achieve remission as well as time to sustained response and sustained remission |
| Assess the time to and rate of relapse to depressive episode following remission for olanzapine/fluoxetine combination compared with lamotrigine |
| Assess the time to and rate of relapse to mania with olanzapine/fluoxetine combination compared with lamotrigine |
| Assess efficacy of treatment in improving symptomatology |
| Evaluate the level of health resource utilization and resource utilization costs associated with olanzapine/fluoxetine combination compared with lamotrigine during the study treatment period |
| Assess the efficacy of olanzapine/fluoxetine combination compared with lamotrigine for suicide ideation |
| Assess the total time of hospitalization of patients on olanzapine/fluoxetine combination compared with lamotrigine during the study treatment period |
| Assess the safety and tolerability of olanzapine/fluoxetine combination compared with lamotrigine during 6 months of therapy |
| The sensitivity and positive predictive value of the MDQ will be determined in this study, using the SCID as a standard |
| To explore possible correlation between changes in eating behavior and changes in body weight |
| United States |
| D006571 | Heterocyclic Compounds |
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D014227 | Triazines |
| D006573 | Heterocyclic Compounds, 1-Ring |