The purpose of this study is to test the efficacy and total costs of olanzapine versus commonly used conventional antipsychotics in Sweden.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
physician determined dose, oral, daily, 5 months
physician determined dose, oral, parenteral (\<= 3 days), daily, 5 months
physician determined dose, oral, parenteral (\<= 3 days), daily, 5 months
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
Time to remission by Young Mania Rating Scale, MADRS-S and CGI-BP
Time frame: 5 months
Resource utilization Clinical Report Form (RUCRF)
Time frame: 5 months
Disability free day assessment (DFDA)
Time frame: 5 months
Medication compliance
Time frame: 5 months
Medical Outcomes Study 36-Item Short Form Health Survey (SF-36)
Time frame: 5 months
Euro Qol instrument
Time frame: 5 months
Drug Attitude Inventory (DAI)
Time frame: 5 months
Response by Y-MRS
Time frame: 5 months
Frequency of and time to relapse into mania by Y-MRS and CGI-BP
Time frame: 5 months
Frequency of and time to switch to depression by MADRS-S and DSRS
Time frame: 5 months
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
Adverse events
Time frame: 5 months
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