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A Study in the Treatment of Acute Mania

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ClinicalTrials.gov Identifier: NCT00767715
Recruitment Status : Terminated (Trial discontinued due to low enrollment)
First Posted : October 7, 2008
Last Update Posted : October 7, 2008
Sponsor:
Information provided by:
Eli Lilly and Company

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

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: olanzapine Drug: haloperidol Drug: zuclopentixol Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2004
Actual Primary Completion Date : April 2005
Actual Study Completion Date : April 2005

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A
Patients will be given olanzapine
Drug: olanzapine
physician determined dose, oral, daily, 5 months
Other Names:
  • LY170053
  • Zyprexa

Active Comparator: B
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




Primary Outcome Measures :
  1. Time to remission by Young Mania Rating Scale, MADRS-S and CGI-BP [ Time Frame: 5 months ]

Secondary Outcome Measures :
  1. Resource utilization Clinical Report Form (RUCRF) [ Time Frame: 5 months ]
  2. Disability free day assessment (DFDA) [ Time Frame: 5 months ]
  3. Medication compliance [ Time Frame: 5 months ]
  4. Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) [ Time Frame: 5 months ]
  5. Euro Qol instrument [ Time Frame: 5 months ]
  6. Drug Attitude Inventory (DAI) [ Time Frame: 5 months ]
  7. Response by Y-MRS [ Time Frame: 5 months ]
  8. Frequency of and time to relapse into mania by Y-MRS and CGI-BP [ Time Frame: 5 months ]
  9. Frequency of and time to switch to depression by MADRS-S and DSRS [ Time Frame: 5 months ]
  10. 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 ]
  11. Adverse events [ Time Frame: 5 months ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00767715


Locations
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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
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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

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Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00767715     History of Changes
Other Study ID Numbers: 7313
F1D-SO-HGLY
First Posted: October 7, 2008    Key Record Dates
Last Update Posted: October 7, 2008
Last Verified: October 2008
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Haloperidol
Olanzapine
Haloperidol decanoate
Clopenthixol
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Dopamine Antagonists
Dopamine Agents
Anti-Dyskinesia Agents