A Study in the Treatment of Acute Mania

Bipolar Disorder Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00767715
• Other study ID #: 7313
• Secondary ID: F1D-SO-HGLY
• Status: Terminated
• Phase: Phase 4
• First received: October 3, 2008
• Last updated: October 3, 2008
• Start date: October 2004
• Est. completion date: April 2005

Study information

• Verified date: October 2008
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: April 2005
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• olanzapine
physician determined dose, oral, daily, 5 months
• haloperidol
physician determined dose, oral, parenteral (<= 3 days), daily, 5 months
• zuclopentixol
physician determined dose, oral, parenteral (<= 3 days), daily, 5 months

Locations

Country	Name	City	State
Sweden	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to remission by Young Mania Rating Scale, MADRS-S and CGI-BP		5 months	No
Secondary	Resource utilization Clinical Report Form (RUCRF)		5 months	No
Secondary	Disability free day assessment (DFDA)		5 months	No
Secondary	Medication compliance		5 months	No
Secondary	Medical Outcomes Study 36-Item Short Form Health Survey (SF-36)		5 months	No
Secondary	Euro Qol instrument		5 months	No
Secondary	Drug Attitude Inventory (DAI)		5 months	No
Secondary	Response by Y-MRS		5 months	No
Secondary	Frequency of and time to relapse into mania by Y-MRS and CGI-BP		5 months	No
Secondary	Frequency of and time to switch to depression by MADRS-S and DSRS		5 months	No
Secondary	Time to remission in patients with psychotic features by SCID-I judgement, Y-MRS item 8 and PANSS positive items mean sum		5 months	No
Secondary	Adverse events		5 months	Yes