A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP STUDY, COMPARING THE EFFICACY AND TOLERABILITY OF ZIPRASIDONE (ZELDOX®, GEODON®) VS OLANZAPINE (ZYPREXA®) IN THE TREATMENT AND MAINTENANCE OF RESPONSE IN PATIENTS WITH ACUTE MANIA - ZOOM STUDY: ZIPRASIDONE AND OLANZAPINE’S OUTCOMES IN MANIA

• Conditions: Bipolar I Disorder; MedDRA version: 8.1Level: LLTClassification code 10057667Term: Bipolar disorder

• Registration Number: EUCTR2005-004391-21-DE
• Lead Sponsor: Pfizer Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-13
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 352

Inclusion Criteria

Demographic and General Inclusion Criteria
Subjects must:
1.Personally sign the written informed consent after the scope and nature of the investigation has been explained to them before any study-specific procedure/evaluation is initiated or performed.
2.Be either male or female.
3.Be at least 18 years of age and at the age of legal consent, and no older than 65 years of age.
4.If female be not of child-bearing potential (i.e. surgically sterile or postmenopausal for at least one year), or be non-pregnant and using an acceptable method of birth control (such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner) for at least one month prior to the screening visit if necessary, and for the duration of the study period.
5.Be likely to comply with the protocol and medication regimen.
6.Be fluent in the language of the investigator and study staff (including raters).
7.Be either an in- or out-patient.

Psychiatric Inclusion Criteria
1.Have a primary diagnosis of Bipolar I Disorder, current episode manic (DSM-IV 296.4x) or mixed (DSM-IV296.6x) as determined by the Structured Clinical Interview for DSM-IV Axis I Disorders, Patient Edition (SCID-P) at screening.
2.A minimum score of 20 on the YMRS at the randomisation visit.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Psychiatric
1.A primary diagnosis other than Bipolar I Disorder.
2.Patients diagnosed with rapid cycling of Bipolar I Disorder.
3.Patients who are an imminent risk of self harm or harm to others.
4.Have a diagnosis of learning disability or organic brain syndrome.
5.Have a substance-induced psychotic disorder or behavioral disturbance thought to be due to substance abuse.
6.Have a current (within 2 months prior to screening) DSM-IV-TR defined substance abuse/dependence (excluding nicotine and caffeine).
7.Have used phencyclidine at any time during the 30-day period preceding screening.
8.Participation in a clinical trial within 1 month before study entry.
9.Have received clozapine within 4 weeks, a depot antipsychotic within 4 weeks or a monoamine oxidase inhibitor within 2 weeks prior to baseline.
10.Have been judged by the investigator to be medically non-compliant in the management of their disease.
11.Patients currently treated with olanzapine or ziprasidone at study start.
12. Ziprasidone or olanzapine treatment had been withdrawn because of clinically important and/or intolerable adverse events or who exhibited a lack of treatment response when these drugs had been given at therapeutic doses and there was good compliance from the patient.
13.Documented history of intolerance to olanzapine or ziprasidone.
14.Be receiving electroconvulsive therapy (ECT) for 4 weeks prior to screening and at any time during the study period.

Medical exclusion criteria
Subjects must not:
1.Have an uncontrolled, unstable clinically significant medical condition (e.g. renal, hepatic, endocrine, respiratory, cardiovascular, heamatologic, immunologic, cerebrovascular disease, or malignancy), including diabetic subjects taking insulin, extreme obesity (BMI >35 kg/m2) or anorexia (BMI <18.5 kg/m2), which, in the opinion of the investigator, may interfere with the interpretation of safety or efficacy evaluations.
2.Have hypokalemia or hypomagnesaemia at screening: These subjects may not be entered into the trial until these electrolytes have been repleted and the laboratory values for potassium and magnesium are within normal limits.
3.Have severe dehydration or sodium depletion. These subjects may not be entered into the trial until these electrolytes have been repleted and the laboratory values for sodium are within normal limits.
4.Have ALT or AST =2X, alkaline phosphatase = 1.2X or total bilirubin = 1.5X times the upper limits of the reference range at the Screening assessment.
5.Have serologic evidence of acute hepatitis or chronic hepatitis (positive HBsAg). Subjects with known hepatitis C antibodies and elevated liver function enzymes will be excluded from study participation.
6.Have a history of significant cardiovascular disease or significant concurrent cardiovascular disease, including uncontrolled hypertension (sitting diastolic pressure >95 mm Hg and/or sitting systolic pressure > 170 mm Hg with or without treatment), hypotension, congestive heart failure, angina pectoris, bypass surgery, history of myocardial infarction or ischemic heart disease, uncompensated heart failure or recent acute myocardial infarction (within the past 6 months).
· Controlled essential hypertension (stable for at least 2 months by diet and/or pharmacotherapy) and non-clinically significant sinus bradycardia and sinus tachycardia will not be considered significant medical illnesses and will not exclude a subject from the study.
7.Have a clin

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this study is to compare the efficacy and tolerability of ziprasidone versus olanzapine in the treatment of acute mania. ;Secondary Objective: An open label extension study will further evaluate the efficacy, safety, and tolerability of ziprasidone compared with olanzapine over a period of 6 months in patient responding to acute treatment.;Primary end point(s): The primary endpoint will be the mean reduction, after 4 weeks of treatment, in the YMRS score during the double blind phase.