Galantamine for Cognition in People With Schizophrenia

NCT00320736 | Completed Phase 4

• 1 other identifier: CORRC 20-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

schizophrenia; cognitive function; cholinergic medication; nicotinic receptor agonist

Outcome Measures

Primary Outcomes (1)

• Improvement from baseline in performance on the cognitive battery: Stroop, Cornblatt CPT-IP, CDR Battery, letter number span, Grooved peg board, Tower of London, and Signal Detection Task.

Secondary Outcomes (1)

• Improvement from baseline in negative symptoms (SANS), depressive symptoms (CDSS) and impulsivity (PANSS aggression item).

Interventions

galantamine DRUG

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• North Suffolk Mental Health Association: lead
• Janssen Medical Affairs: collaborator

Study Sites (1)

Freedom Trail Clinic

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Galantamine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• A Eden Evins, MD, MPH

  North Suffolk Mental Health Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 28, 2006
• First Posted: May 3, 2006
• Study Start: January 1, 2004
• Study Completion: May 1, 2006
• Last Updated: May 19, 2009

Record last verified: 2009-05

Locations

US (1)