Galantamine for Cognitive Deficits in Schizophrenia

NCT00463879 | Completed Phase 2

• 1 other identifier: 0508000458
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Cognition; Smoking; Galantamine; Nicotine; Cognitive Deficits

Outcome Measures

Primary Outcomes (1)

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

Interventions

Galantamine DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Alliance for Research on Schizophrenia and Depression: collaborator

Study Sites (1)

Connecticut Mental Health Center, Yale School of Medicine

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Schizophrenia; Smoking; Cognition Disorders

Interventions

Galantamine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavior; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Amaryllidaceae Alkaloids; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Tony P George, M.D.

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 18, 2007
• First Posted: April 20, 2007
• Study Start: September 1, 2005
• Study Completion: September 1, 2007
• Last Updated: December 12, 2007

Record last verified: 2007-12

Locations

US (1)