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Neurocognitive Effects of Ziprasidone: Relationship to Working Memory and Dopamine Blockade

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ClinicalTrials.gov Identifier: NCT00225498
Recruitment Status : Completed
First Posted : September 23, 2005
Results First Posted : September 10, 2015
Last Update Posted : September 10, 2015
Sponsor:
Information provided by (Responsible Party):
Anil K. Malhotra, Northwell Health

Brief Summary:
Ziprasidone is a newer drug intended for the treatment of the symptoms of schizophrenia. This new drug may have an added benefit of being able to help with some of the difficulties in problem solving and memory that many patients with schizophrenia experience. The present study wants to look at ziprasidone and two other drugs frequently used to treat the symptoms of schizophrenia (risperidone and olanzapine) to see if problem solving and memory get better with ziprasidone treatment. Moreover, we will look at symptoms and how they change with treatment.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: ziprasidone vs risperidone or olanzapine Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neurocognitive Effects of Ziprasidone: Relationship to Working Memory and Dopamine Blockade
Study Start Date : June 2002
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008


Arm Intervention/treatment
Experimental: 1
ziprasidone
Drug: ziprasidone vs risperidone or olanzapine
ziprasidone target dose is 160 mg/day risperidone target dose is 4 mg/day olanzapine target dose is 20 mg/day
Other Name: Geodon vs Risperdal or Zyprexa
Active Comparator: 2
risperidone or olanzapine
Drug: ziprasidone vs risperidone or olanzapine
ziprasidone target dose is 160 mg/day risperidone target dose is 4 mg/day olanzapine target dose is 20 mg/day
Other Name: Geodon vs Risperdal or Zyprexa



Primary Outcome Measures :
  1. Working Memory [ Time Frame: 3 months ]

    California Verbal Learning Test (CVLT) trials 1 through 5 is a well established neuropsychological test of working memory. The maximum score is 80 which reflects a better outcome and the minimum score is 0 which reflects a worse outcome.

    The only meaningful analyses with adequate statistical power that could be reported were of the 10 schizophrenia patients who met nonresponse criteria to ziprasidone. The overall enrollment of 35 subjects was insufficient to perform the originally planned analyses in a statistically valid manner.




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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of schizophrenia, schizoaffective disorder or schizophreniform disorder
  • Ages 18 - 50
  • Ability to provide written informed consent
  • Brief Psychiatric Rating Scale (BPRS) total score > 40 and Clinical Global Impressions (CGI) > 4 (moderately ill) and/or intolerant to current antipsychotic drug treatment

Exclusion Criteria:

  • History of prior treatment with ziprasidone
  • History of medical condition that contraindicates ziprasidone treatment
  • Treatment with depot antipsychotic medication in past 3 months
  • Current diagnosis of alcohol or psychoactive substance dependence
  • Impaired ability to provide written informed consent

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): NCT00225498


Locations
United States, New York
The Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004
Sponsors and Collaborators
Northwell Health
Investigators
Principal Investigator: Anil K Malhotra, M.D. Psychiatry Research The Zucker Hillside Hospital

Publications:
Responsible Party: Anil K. Malhotra, Director, Psychiatry Research, Northwell Health
ClinicalTrials.gov Identifier: NCT00225498     History of Changes
Other Study ID Numbers: 01-04-200
First Posted: September 23, 2005    Key Record Dates
Results First Posted: September 10, 2015
Last Update Posted: September 10, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Ziprasidone
Olanzapine
Dopamine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Cardiotonic Agents
Sympathomimetics
Protective Agents