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Efficacy Study of Galantamine for Cognitive Impairments in Schizophrenia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00176423
First Posted: September 15, 2005
Last Update Posted: June 27, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Stanley Medical Research Institute
Ortho-McNeil Neurologics, Inc.
Information provided by:
University of Maryland
  Purpose
The purpose of this study is to examine whether adjunctive galantamine is effective in the treatment of cognitive impairments in patients with schizophrenia.

Condition Intervention Phase
Schizophrenia Schizoaffective Disorder Drug: galantamine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Adjunctive Galantamine for Treatment of Cognitive Impairments in Patients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Neuropsychological test battery composite score at 12 weeks; p50 T/C ratio at 12 weeks; P300 amplitude at 12 weeks
  • Smooth pursuit eye movement gain at 12 weeks

Secondary Outcome Measures:
  • Positive symptoms as measured by the BPRS positive symptom item total score; Negative symptoms as measured by the SANS total score; Side effects as measured by the Side Effect Checklist
  • Smoking behavior as measured by the Fagerstrom Nicotine Dependency Test at 12 weeks.

Estimated Enrollment: 120
Study Start Date: May 2002
Study Completion Date: December 2006
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. DSM-IV diagnosis of either schizophrenia or schizoaffective disorder.
  2. Males and females
  3. Age: 18 and 60
  4. Caucasian or Non-Caucasian
  5. Subjects will be currently treated with one of the following new generation antipsychotics: olanzapine, risperidone, quetiapine, ziprasidone, or aripiprazole.
  6. Subjects will meet a priori criteria for cognitive impairment severity. The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) will be used to determine the level of cognitive impairment. Patients will meet entry criteria if they have a RBANS total score of 90 or less (one standard deviation below the normal control mean).

Exclusion Criteria:

  1. History of an organic brain disease
  2. History of DSM-IV alcohol or substance abuse (within the last month), or DSM-IV alcohol or substance dependence (within the last six months).
  3. Pregnant women and women taking oral contraceptives (because of the theoretical risk of breakthrough ovulation).
  4. Current treatment with galantamine or other acetylcholinesterase inhibitor (e.g. donepezil)
  5. History of a second or third degree atrioventricular (AV) block.
  6. Persons with chronic medical conditions, which are unstable.
  Contacts and Locations
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): NCT00176423


Locations
United States, Maryland
Maryland Psychiatric Research Center
Baltimore, Maryland, United States, 21228
Sponsors and Collaborators
University of Maryland
Stanley Medical Research Institute
Ortho-McNeil Neurologics, Inc.
Investigators
Principal Investigator: Robert W Buchanan, M.D. University of Maryland Baltimore School of Medicine, Maryland Psychiatric Research Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00176423     History of Changes
Other Study ID Numbers: 01T-411
First Submitted: September 9, 2005
First Posted: September 15, 2005
Last Update Posted: June 27, 2007
Last Verified: June 2007

Keywords provided by University of Maryland:
schizophrenia
acetylcholine
cognitive impairments
attention
processing speed
sensory gating
eye-tracking

Additional relevant MeSH terms:
Schizophrenia
Cognitive Dysfunction
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Cognition Disorders
Neurocognitive Disorders
Galantamine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents