Galantamine for Cognitive Deficits in Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00463879
First received: April 18, 2007
Last updated: December 11, 2007
Last verified: December 2007
  Purpose

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 Intervention Phase
Schizophrenia
Drug: Galantamine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Galantamine for Cognitive Deficits in Schizophrenia

Resource links provided by NLM:


Further study details as provided by Yale University:

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

Enrollment: 21
Study Start Date: September 2005
Study Completion Date: September 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00463879

Locations
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
Investigators
Principal Investigator: Tony P George, M.D. University of Toronto
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00463879     History of Changes
Other Study ID Numbers: 0508000458
Study First Received: April 18, 2007
Last Updated: December 11, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Schizophrenia
Cognition
Smoking
Galantamine
Nicotine
Cognitive Deficits

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

ClinicalTrials.gov processed this record on October 29, 2014