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Galantamine for Cognitive Deficits in Schizophrenia

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ClinicalTrials.gov Identifier: NCT00463879
Recruitment Status : Completed
First Posted : April 20, 2007
Last Update Posted : December 12, 2007
National Alliance for Research on Schizophrenia and Depression
Information provided by:
Yale University

Brief Summary:
The purpose of this study is to determine the acute effects of the nicotinic receptor allosteric modulator galantamine (0, 4 and 8 mg) on neurocognitive function in schizophrenic smokers (n=20) versus schizophrenic nonsmokers (n=10) in an outpatient human laboratory setting.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Galantamine Phase 2 Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Galantamine for Cognitive Deficits in Schizophrenia
Study Start Date : September 2005
Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Primary Outcome Measures :
  1. 1. Change on selected cognitive deficits associated with schizophrenia (e.g., spatial working memory, sustained attention and prepulse inhibition.)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Schizophrenic smokers (n=20) and schizophrenic nonsmokers (n=10) in these studies (total n=20 subjects) will be:

  1. Between 18 and 60 years of age,
  2. Have a Full Scale IQ score >80.
  3. Smokers will meet DSM-IV criteria for nicotine dependence, and smoke at least 15 cigarettes per day, with an FTND score at baseline >5, breath CO >10, and plasma cotinine >150 ng/ml.
  4. Nonsmokers will report a history of never smoking (<100 cigarettes lifetime) or be abstinent from smoking for at least 6 months prior to randomization, with abstinence biochemically confirmed by CO level <10 ppm and plasma cotinine <15 ng/ml.
  5. Schizophrenic subjects will meet DSM-IV criteria for schizophrenia or schizoaffective disorder, and be on a stable dose of antipsychotic medication for at least three months, with positive symptoms stability as judged by the investigator.
  6. Subjects must be non-treatment seeking smokers with respect to their nicotine dependence.

Exclusion Criteria:

  1. Meet criteria for current abuse or dependence for any other alcohol or substance of abuse within the past 6 months, with the exception of nicotine dependence (smokers) or caffeine (all groups).
  2. An inability to learn the neuropsychological tasks during the training session.
  3. History of dementia, other neurological illness (e.g. idiopathic Parkinson's Disease, Epilepsy), or any other acute or chronic medical condition known to significantly influence neurocognitive function, at the discretion of the P.I. and Project Director.
  4. A history of severe renal or hepatic insufficiency, or a known hypersensitivity to galantamine hydrochloride (Razadyne®).
  5. For smokers, current use of any tobacco products (chewing tobacco, cigars, nicotine replacement therapies like lozenges, gum, nasal spray, inhaler or patch) besides cigarettes.
  6. A history of hypotension, or currently taking anti-hypertensive medication.
  7. Interested in quitting smoking (in which case they will be referred to our smoking cessation treatment study).
  8. Not capable of giving informed consent for participation in this study.
  9. Positive urine toxicology screen for any substance of abuse.
  10. Patients who are pregnant or planning on becoming pregnant.

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): NCT00463879

United States, Connecticut
Connecticut Mental Health Center, Yale School of Medicine
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
National Alliance for Research on Schizophrenia and Depression
Principal Investigator: Tony P George, M.D. University of Toronto

ClinicalTrials.gov Identifier: NCT00463879     History of Changes
Other Study ID Numbers: 0508000458
First Posted: April 20, 2007    Key Record Dates
Last Update Posted: December 12, 2007
Last Verified: December 2007

Keywords provided by Yale University:
Cognitive Deficits

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