A Study in the Treatment of Acute Mania

Condition(s) targeted: Bipolar Disorder

Intervention: olanzapine (Drug); haloperidol (Drug); zuclopentixol (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company

The purpose of this study is to test the efficacy and total costs of olanzapine versus commonly used conventional antipsychotics in Sweden.

Official title: A Randomized Open Label Study on the Efficacy, Tolerability, and Total Costs of Olanzapine Versus Conventional Antipsychotics in the Treatment of Acute Mania in Sweden

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Time to remission by Young Mania Rating Scale, MADRS-S and CGI-BP

Secondary outcome:

Resource utilization Clinical Report Form (RUCRF)

Disability free day assessment (DFDA)

Medication compliance

Medical Outcomes Study 36-Item Short Form Health Survey (SF-36)

Euro Qol instrument

Drug Attitude Inventory (DAI)

Response by Y-MRS

Frequency of and time to relapse into mania by Y-MRS and CGI-BP

Frequency of and time to switch to depression by MADRS-S and DSRS

Time to remission in patients with psychotic features by SCID-I judgement, Y-MRS item 8 and PANSS positive items mean sum

Adverse events

Detailed description: The primary objective is to show that the efficacy of olanzapine is non-inferior to the conventional antipsychotics haloperidol or zuclopentixol in the treatment of an acute manic or mixed episode of bipolar disorder. Efficacy is defined as time to remission, as measured by the total scores of the Young Mania Rating Scale (Y-MRS), MADRS-S, and Clinical Global

Impression - Bipolar (CGI-BP). Time from baseline to remission is defined as the primary

efficacy measure. Remission is defined as a Y-MRS score <=12 AND a MADRS-S score <=12 AND CGI-BP = 1 or 2. Secondary efficacy assessments will include time from baseline to

- Response, as defined as a reduction of Y-MRS score greater than or equal to 50%

compared to baseline

- Relapse of mania, as defined as a Y-MRS score >= 16 AND CGI-BP >2 after having met the

criteria for remission

- Switch into depression, as defined as a MADRS-S score >=17 AND fulfilled criteria for

Major Depression as self-assessed by DSRS.

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of bipolar I disorder and currently display an acute manic or mixed episode

(with or without psychotic features)

- Patients must have a Y-MRS total score of greater or equal to 20 at visit 2

- Patients must have experienced at least one manic or mixed episode prior to study

enrollment

- Female of childbearing potential must be using a medically accepted means of

contraception, or practice sexual abstinence

- Each patient must have a level of understanding sufficient to communicate

intelligently with study personnel

- Patients must be considered reliable

- Each patient must understand the nature of the study and signed informed consent

Exclusion Criteria:

- Female patients who are pregnant or lactating

- Serious, unstable illnesses such that hospitalization for the disease is anticipated

within 3 month or death is anticipated within 3 years

- Uncorrected hypothyroidism or hyperthyroidism

- Narrow-angle glaucoma

- History of allergic reactions or intolerance to study medications

- DSM-IV substance dependence within the past 30 days at the judgement of the

investigator

- Judged clinically to be at serious suicidal risk

- Treatment with an injectable depot neuroleptic within less than one dosing interval

between depot neuroleptic injections prior to visit 2

- Any patient treated with clozapine within 4 weeks prior to visit 2

- Subjects who have received treatment with ECT within one month prior to visit 1

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., Danderyd, Sweden

Starting date: October 2004
Last updated: October 3, 2008