A Study in the Treatment of Acute Mania - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00767715

Purpose

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

Condition	Intervention	Phase
Bipolar Disorder	Drug: olanzapine Drug: haloperidol Drug: zuclopentixol	Phase IV

MedlinePlus related topics: Bipolar Disorder

Drug Information available for: Olanzapine Haloperidol Haloperidol decanoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
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

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Time to remission by Young Mania Rating Scale, MADRS-S and CGI-BP [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Resource utilization Clinical Report Form (RUCRF) [ Time Frame: 5 months ] [ Designated as safety issue: No ]
Disability free day assessment (DFDA) [ Time Frame: 5 months ] [ Designated as safety issue: No ]
Medication compliance [ Time Frame: 5 months ] [ Designated as safety issue: No ]
Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) [ Time Frame: 5 months ] [ Designated as safety issue: No ]
Euro Qol instrument [ Time Frame: 5 months ] [ Designated as safety issue: No ]
Drug Attitude Inventory (DAI) [ Time Frame: 5 months ] [ Designated as safety issue: No ]
Response by Y-MRS [ Time Frame: 5 months ] [ Designated as safety issue: No ]
Frequency of and time to relapse into mania by Y-MRS and CGI-BP [ Time Frame: 5 months ] [ Designated as safety issue: No ]
Frequency of and time to switch to depression by MADRS-S and DSRS [ Time Frame: 5 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]

Enrollment:	11
Study Start Date:	October 2004
Study Completion Date:	April 2005
Primary Completion Date:	April 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Patients will be given olanzapine	Drug: olanzapine physician determined dose, oral, daily, 5 months
B: Active Comparator Patients will be given either haloperidol or zuclopentixol	Drug: haloperidol physician determined dose, oral, parenteral (<= 3 days), daily, 5 months Drug: zuclopentixol physician determined dose, oral, parenteral (<= 3 days), daily, 5 months

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00767715

Locations

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, Sweden

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

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)

Eli Lilly and Company

More Information

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	7313, F1D-SO-HGLY
Study First Received:	October 3, 2008
Last Updated:	October 3, 2008
ClinicalTrials.gov Identifier:	NCT00767715
Health Authority:	Sweden: Medical Products Agency

Study placed in the following topic categories:

Haloperidol
Haloperidol decanoate
Affective Disorders, Psychotic
Dopamine
Mental Disorders

Bipolar Disorder
Olanzapine
Mood Disorders
Psychotic Disorders
Serotonin

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants

Dopamine Antagonists
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009