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lithium · 1 trial · 1 indication
The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. The primary objective was only interested in the effects in the olanzapine monotherapy arm.
Defined by a 50% or more reduction in YMRS total score from baseline in Study BMAC to endpoint. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. The primary objective was only interested in the effects in the olanzapine monotherapy arm.
Remission of Mania was defined as a YMRS total score of less than or equal to 12 at endpoint. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. The primary objective was only interested in the effects in the olanzapine monotherapy arm.
Patients achieved remission in Study BMAC (defined as YMRS total score \<=12 and HAMD-17 total score \<=7) and obtained YMRS total score of \>=15 at any time during Study BMEX. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. The primary objective was only interested in the effects in the olanzapine monotherapy arm.
| Arm | Type | Description |
|---|---|---|
| Olanzapine Monotherapy | EXPERIMENTAL | Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks. |
| Olanzapine + Mood Stabilizer | EXPERIMENTAL | Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks. |
| Name | Type | Description |
|---|---|---|
| olanzapine | DRUG | oral, daily |
| lithium | DRUG | Dose adjusted according to local package insert |
| valproate | DRUG | Dose adjusted according to local package insert |
| carbamazepine | DRUG | Dose adjusted according to local package insert |
Inclusion Criteria: * Enrolled in and completed Study BMAC (NCT00129220), or those who discontinued Study BMAC at Visit 4 or Visit 5 due to lack of efficacy and for whom the Young Mania Rating Scale (YMRS) total score at the time of discontinuation was not lower than that at baseline of Study BMAC ...
Lithium is being studied for the treatment of manic or mixed episodes associated with bipolar I disorder. Eli Lilly and Company is developing it in this psychiatric indication, and the program has reached Phase 3 clinical development. It is a small molecule therapy.
Eli Lilly and Company, which trades under the ticker LLY, is the developer of lithium for manic or mixed episodes associated with bipolar I disorder. The company is responsible for the clinical program evaluating this small molecule in Phase 3 development.
Lithium is in Phase 3 clinical development for manic or mixed episodes associated with bipolar I disorder. It is an investigational therapy and has not been approved by the FDA for this use. The Phase 3 program includes one completed trial.
Lithium has been evaluated in one completed Phase 3 trial, NCT00266630, titled Efficacy and Safety of Olanzapine in the Extended Treatment for Manic or Mixed Episode of Bipolar I Disorder. The trial enrolled 139 participants in Japan and included adults aged 20 years and older.
Lithium is an investigational therapy in Phase 3 development for manic or mixed episodes associated with bipolar I disorder and has not been approved by the FDA for this indication. The clinical program includes one completed Phase 3 trial.