A Study in the Treatment of Acute Mania

Lilly

Status and phase

Terminated

Phase 4

Conditions

Bipolar Disorder

Treatments

Drug: olanzapine

Drug: zuclopentixol

Drug: haloperidol

Study type

Interventional

Funder types

Industry

Identifiers

NCT00767715

7313 (Other Identifier)

F1D-SO-HGLY

Details and patient eligibility

About

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

Full 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.

Enrollment

11 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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