Galantamine for Cognition in People With Schizophrenia

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

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 disorder. Twenty subjects on a stable dose of antipsychotic medications receive galantamine or identical placebo tablets for 8 weeks. Adverse events are screened for every week. Tests of memory, attention, and reward responsivity are performed at baseline and afer 8 weeks on medication. Clinical scales rating psychiatric symptoms are performed at the beginning, middle, and end of the trial.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: North Suffolk Mental Health Association
• Collaborator: Janssen Medical Affairs
• Treatments: Galantamine

Criteria

Inclusion Criteria:

1. Diagnosis of schizophrenia or schizoaffective disorder depressed type with stable psychiatric symptoms, no active suicidal ideation

2. Age 18-60, inclusive

3. Stable medical conditions such as hypertension, non-insulin-dependent diabetes, hypothyroidism allowed

4. Treated with antipsychotic medications at a stable dose for > 4 weeks

5. Not treated with investigational medications in the past 30 days

6. Competent to provide informed consent

7. WRAT-3 IQ raw score greater than or equal to 35

8. Expired CO level < 9 ppm

9. Salivary cotinine level < 30 ng/ml

10. Non-smoker for at least 3 months

Exclusion Criteria:

1. Diagnosis of dementia, neurodegenerative disease or any other current Axis I DSM-IV diagnosis

2. Any unstable medical illness, asthma requiring daily treatment, severe COPD, active peptic ulcer disease, gastrointestinal bleeding, atrioventricular block, urinary outflow obstruction, history of epilepsy

3. Concurrent use of anticholinergic medications or use of cholinomimetic medications in the past month, such as cogentin, donepezil or clozapine

4. Alcohol or substance abuse in the past month (self-report and confirmed by chart)

5. Known allergy or hypersensitivity to galantamine

6. Current treatment with erythromycin or ketoconazole

7. Concurrent use of NSAIDs

8. Women of childbearing potential

9. History of suicide attempt in the past year