search
Back to results

A Study in the Treatment of Acute Mania

Primary Purpose

Bipolar Disorder

Status
Terminated
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
olanzapine
haloperidol
zuclopentixol
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / 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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Patients will be given olanzapine

Patients will be given either haloperidol or zuclopentixol

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 3, 2008
Last Updated
October 3, 2008
Sponsor
Eli Lilly and Company
search

1. Study Identification

Unique Protocol Identification Number
NCT00767715
Brief Title
A Study in the Treatment of Acute Mania
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 Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Terminated
Why Stopped
Trial discontinued due to low enrollment
Study Start Date
October 2004 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
April 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Patients will be given olanzapine
Arm Title
B
Arm Type
Active Comparator
Arm Description
Patients will be given either haloperidol or zuclopentixol
Intervention Type
Drug
Intervention Name(s)
olanzapine
Other Intervention Name(s)
LY170053, Zyprexa
Intervention Description
physician determined dose, oral, daily, 5 months
Intervention Type
Drug
Intervention Name(s)
haloperidol
Intervention Description
physician determined dose, oral, parenteral (<= 3 days), daily, 5 months
Intervention Type
Drug
Intervention Name(s)
zuclopentixol
Intervention Description
physician determined dose, oral, parenteral (<= 3 days), daily, 5 months
Primary Outcome Measure Information:
Title
Time to remission by Young Mania Rating Scale, MADRS-S and CGI-BP
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Resource utilization Clinical Report Form (RUCRF)
Time Frame
5 months
Title
Disability free day assessment (DFDA)
Time Frame
5 months
Title
Medication compliance
Time Frame
5 months
Title
Medical Outcomes Study 36-Item Short Form Health Survey (SF-36)
Time Frame
5 months
Title
Euro Qol instrument
Time Frame
5 months
Title
Drug Attitude Inventory (DAI)
Time Frame
5 months
Title
Response by Y-MRS
Time Frame
5 months
Title
Frequency of and time to relapse into mania by Y-MRS and CGI-BP
Time Frame
5 months
Title
Frequency of and time to switch to depression by MADRS-S and DSRS
Time Frame
5 months
Title
Time to remission in patients with psychotic features by SCID-I judgement, Y-MRS item 8 and PANSS positive items mean sum
Time Frame
5 months
Title
Adverse events
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Danderyd
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

A Study in the Treatment of Acute Mania

We'll reach out to this number within 24 hrs