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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anil K. Malhotra, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00225498
First received: September 21, 2005
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

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 Intervention
Schizophrenia
Drug: ziprasidone vs risperidone or olanzapine

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neurocognitive Effects of Ziprasidone: Relationship to Working Memory and Dopamine Blockade

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • working memory [ Time Frame: baseline, 1 month, 2 months, 3 months ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: June 2002
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of schizophrenia, schizoaffective disorder or schizophreniform disorder
  • Ages 18 - 50
  • Ability to provide written informed consent
  • BPRS total score > 40 and 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00225498

Locations
United States, New York
The Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Investigators
Principal Investigator: Anil K Malhotra, M.D. Psychiatry Research The Zucker Hillside Hospital
  More Information

Publications:
Responsible Party: Anil K. Malhotra, Director, Psychiatry Research, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT00225498     History of Changes
Other Study ID Numbers: 01-04-200
Study First Received: September 21, 2005
Last Updated: April 26, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Dopamine
Risperidone
Ziprasidone
Olanzapine
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Serotonin Antagonists
Serotonin Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Psychotropic Drugs
Dopamine Antagonists
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Antiemetics

ClinicalTrials.gov processed this record on April 15, 2014