Conditions

Depression, Bipolar

Outcome Measures

Primary Outcomes (1)

Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Acute Phase)
The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Baseline, Endpoint (Week 6)

Secondary Outcomes (51)

Percentage of Participants With Symptomatic Response at Endpoint (Acute Phase)
Endpoint (Week 6)
Percentage of Participants With Symptomatic Remission At Any Time (Acute Phase)
Baseline through Endpoint (Week 6)
Change From Baseline to Endpoint in Clinical Global Improvement- Bipolar (CGI-BP) Severity of Illness Scores-Mania, Depression, Overall Bipolar Illness Scores (Acute Phase)
Baseline, Endpoint (Week 6)
Percentage of Participants With Recovery (Acute Phase)
Baseline through Endpoint (Week 6 )
Change From Baseline to Endpoint in Young Mania Rating Scale (YMRS) Total Score (Acute Phase)
Baseline, Endpoint (Week 6)
+46 more secondary outcomes

Study Arms (3)

Olanzapine

EXPERIMENTAL

During double-blind treatment, participants receive olanzapine at a dose of 5 milligram (mg) which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.

Drug: Olanzapine

Placebo

PLACEBO COMPARATOR

Matching placebo administered once daily, by mouth during double-blind treatment.

Drug: Placebo

Olanzapine (open-label treatment period)

EXPERIMENTAL

During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and Week 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.

Drug: Olanzapine

Interventions

OlanzapineDRUG

5-20 mg, oral, once daily, for 24 weeks (participants randomized to olanzapine in double-blind treatment period) or 18 weeks (participants randomized to placebo in double-blind treatment period).

Also known as: LY170053, Zyprexa

OlanzapineOlanzapine (open-label treatment period)

PlaceboDRUG

placebo tablets, oral, once daily at bedtime, 6 weeks

Placebo

Eligibility Criteria

Age18 Years - 64 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Each patient must be reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, and must understand the nature of the study and have provided informed consent
All female patients must test negative for pregnancy and females of breast-feeding potential must agree not to breastfeed an infant during the study and for 1 month following the last dose of study drug
Patients must fulfill the criteria for a major depressive episode according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV-TR) as well as criteria for bipolar I disorder, depressed, as defined in the DSM-IV-TR, based on clinical assessment and confirmed by the structured diagnostic interview, the Mini International Neuropsychiatric Interview (MINI), at study entry
Patients must have a current 17-item Hamilton Depression Rating Scale (HAMD-17) score greater than or equal to 18 at Visit 1 and Visit 2
Patients must have a current Young Mania Rating Scale (YMRS) total score less than or equal to 8 at Visit 2.

You may not qualify if:

Has received treatment within the past 30 days with a drug (not including study drug) that has not received regulatory approval for any indication at the time of study entry
Has participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) before study entry
Was previously treated with olanzapine and had bipolar depression considered to be treatment-resistant to olanzapine or to olanzapine in combination with an available selective serotonin reuptake inhibitor (SSRI)
Is experiencing (at the time of study entry) a current episode of bipolar depression that is greater than 90 days in duration
Has been treatment-resistant to any therapy prescribed for bipolar depression when olanzapine alone or with an SSRI prescribed at an appropriate dose and duration

Contact the study team to confirm eligibility.