Kahn Study; Investigation Of The Efficacy Of Ziprasidone Versus Olanzapine In The Management Of Recent-Onset Psychosis; A Flexible-Dose, Parallel Group, Double-Blind Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2005-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study intends to compare novel antipsychotics ziprasidone and olanzapine, to confirm the findings of an open study -where stable patients receiving olanzapine switched to ziprasidone- which showed maintenance of clinical effect with improvements in all domains of cognitive function at 6 weeks (Daniel, 1999). Direct comparison of the two agents in a well-controlled double-blind fashion will allow an evaluation of the effect on cognitive function in the short and long-term management of patients with recent-onset schizophrenia, schizoaffective and schizophreniform disorder.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of the Efficacy and Safety of Intramuscular Ziprasidone Followed by Oral Ziprasidone for the Treatment of Psychosis

NCT00644800

Schizophrenia Mania Delusional Disorder +1 more

COMPLETED PHASE4

Non-interventional Study of Ziprasidone in the Treatment of Bipolar and Schizoaffective Disorders.

NCT00454883

Affective Psychosis, Bipolar Mania Manic-Depressive Psychosis

COMPLETED

Open-label Trial Characterizing the PK of 3 SC Olanzapine Extended-release Formulations in Participants With Schizophrenia/Schizoaffective Disorder

NCT06319170

Schizophrenia, Schizoaffective Disorder

COMPLETED PHASE1

Olanzapine Versus Active Comparator in the Treatment of Depression in Patients With Schizophrenia

NCT00034801

Depression Schizophrenia Schizoaffective Disorder

COMPLETED PHASE4

Large Simple Trial (LST) Of Cardiovascular Safety Of Ziprasidone And Olanzapine- (Zodiac)

NCT00418171

Schizophrenia

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia Psychotic Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

olanzapine

Intervention Type DRUG

ziprasidone

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Duration of illness \< 5 years (according to DSM-IV and onset first psychotic episode); CGI severity score \> 4 (moderately ill)
* maximum exposure to antipsychotic treatment of =\< 16 weeks.

Exclusion Criteria

* Concurrent treatment with antipsychotic agents =\< 12 hours prior to randomization
* for depot agents a period of two weeks or one cycle, whichever is the longer, must occur between last administration and randomization
* Treatment with antidepressants or mood stabilizers =\< 7 days of randomization
* for MAOIs and moclobemide this period must =\< 2 weeks
* for fluoxetine =\< 5 weeks

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No