A Study in the Treatment of Acute Mania

NCT ID: NCT00767715

Last Updated: 2008-10-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2005-04-30

Brief Summary

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

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.

Conditions

Bipolar Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Patients will be given olanzapine

Group Type: EXPERIMENTAL

olanzapine

Intervention Type: DRUG

physician determined dose, oral, daily, 5 months

B

Patients will be given either haloperidol or zuclopentixol

Group Type: ACTIVE_COMPARATOR

haloperidol

Intervention Type: DRUG

physician determined dose, oral, parenteral (\<= 3 days), daily, 5 months

zuclopentixol

Intervention Type: DRUG

physician determined dose, oral, parenteral (\<= 3 days), daily, 5 months

Interventions

olanzapine

physician determined dose, oral, daily, 5 months

Intervention Type: DRUG

haloperidol

physician determined dose, oral, parenteral (\<= 3 days), daily, 5 months

Intervention Type: DRUG

zuclopentixol

physician determined dose, oral, parenteral (\<= 3 days), daily, 5 months

Intervention Type: DRUG

Other Intervention Names

LY170053; Zyprexa

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Eli Lilly

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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

Countries

Sweden

Other Identifiers

F1D-SO-HGLY

Identifier Type: -

Identifier Source: secondary_id

7313

Identifier Type: -

Identifier Source: org_study_id