Galantamine for Cognitive Deficits in Schizophrenia
This study has been completed.
Sponsor:
Yale University
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
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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:
- Between 18 and 60 years of age,
- Have a Full Scale IQ score >80.
- 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.
- 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.
- 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.
- Subjects must be non-treatment seeking smokers with respect to their nicotine dependence.
Exclusion Criteria:
- 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).
- An inability to learn the neuropsychological tasks during the training session.
- 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.
- A history of severe renal or hepatic insufficiency, or a known hypersensitivity to galantamine hydrochloride (Razadyne®).
- For smokers, current use of any tobacco products (chewing tobacco, cigars, nicotine replacement therapies like lozenges, gum, nasal spray, inhaler or patch) besides cigarettes.
- A history of hypotension, or currently taking anti-hypertensive medication.
- Interested in quitting smoking (in which case they will be referred to our smoking cessation treatment study).
- Not capable of giving informed consent for participation in this study.
- Positive urine toxicology screen for any substance of abuse.
- Patients who are pregnant or planning on becoming pregnant.
Contacts and Locations
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 Schizophrenia and Disorders with Psychotic Features Mental 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 June 17, 2013