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Efficacy Study of Galantamine for Cognitive Impairments in Schizophrenia

This study has been completed.
Sponsor:
Collaborators:
Stanley Medical Research Institute
Ortho-McNeil Neurologics, Inc.
Information provided by:
University of Maryland
ClinicalTrials.gov Identifier:
NCT00176423
First received: September 9, 2005
Last updated: June 26, 2007
Last verified: June 2007
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Adjunctive Galantamine for Treatment of Cognitive Impairments in Patients With Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of Maryland

Additional 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
Study First Received: September 9, 2005
Last Updated: June 26, 2007
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Cognition Disorders
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Galantamine
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on May 23, 2013