Status:
COMPLETED
Galantamine for Cognition in People With Schizophrenia
Lead Sponsor:
North Suffolk Mental Health Association
Collaborating Sponsors:
Janssen Medical Affairs
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
This study is a double-blind, placebo-controlled trial of the nicotinic receptor agonist, galantamine, for the improvement of memory and attention in people with schizophrenia and schizoaffective diso...
Detailed Description
Background: Galantamine is a novel acetylcholinesterase inhibitor that is also a positive allosteric modulator of nicotinic acetylcholine receptors. Galantamine has been shown to increase conductivit...
Eligibility Criteria
Inclusion
- Diagnosis of schizophrenia or schizoaffective disorder depressed type with stable psychiatric symptoms, no active suicidal ideation
- Age 18-60, inclusive
- Stable medical conditions such as hypertension, non-insulin-dependent diabetes, hypothyroidism allowed
- Treated with antipsychotic medications at a stable dose for \> 4 weeks
- Not treated with investigational medications in the past 30 days
- Competent to provide informed consent
- WRAT-3 IQ raw score greater than or equal to 35
- Expired CO level \< 9 ppm
- Salivary cotinine level \< 30 ng/ml
- Non-smoker for at least 3 months
Exclusion
- Diagnosis of dementia, neurodegenerative disease or any other current Axis I DSM-IV diagnosis
- Any unstable medical illness, asthma requiring daily treatment, severe COPD, active peptic ulcer disease, gastrointestinal bleeding, atrioventricular block, urinary outflow obstruction, history of epilepsy
- Concurrent use of anticholinergic medications or use of cholinomimetic medications in the past month, such as cogentin, donepezil or clozapine
- Alcohol or substance abuse in the past month (self-report and confirmed by chart)
- Known allergy or hypersensitivity to galantamine
- Current treatment with erythromycin or ketoconazole
- Concurrent use of NSAIDs
- Women of childbearing potential
- History of suicide attempt in the past year
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00320736
Start Date
January 1 2004
End Date
May 1 2006
Last Update
May 19 2009
Active Locations (1)
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1
Freedom Trail Clinic
Boston, Massachusetts, United States, 02114