Efficacy of Galantamine to Treat Schizophrenia
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label Trial of Adjunctive Galantamine Maintenance Therapy to Treat Functional Impairments in Chronic Outpatients With Schizophrenia|
- score on a measure of quality of life [ Time Frame: after 9 months treatment ] [ Designated as safety issue: No ]
- score on a measure of independent living skills [ Time Frame: after 9 months treatment ] [ Designated as safety issue: No ]
- score on a measure of psychopathology [ Time Frame: after 9 months treatment ] [ Designated as safety issue: No ]
- score on a measure of negative symptoms [ Time Frame: after 9 months treatment ] [ Designated as safety issue: No ]
- score on a neurocognitive battery [ Time Frame: after 9 months treatment ] [ Designated as safety issue: No ]
|Study Start Date:||February 2005|
|Study Completion Date:||June 2007|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
Experimental: Intervention group
All subjects enrolled in study are in the intervention group.
open label galantamine, dosed at 4-12 mg/b.i.d., with a target dose of 12 mg/b.i.d.
A majority of patients with schizophrenia or schizoaffective disorder experience impairments in social relations and employment. Many patients experience impairments in their ability to live independently, requiring assistance in such activities as money management, shopping, food preparation and hygiene. These impairments in functioning have been shown to be related to cognitive deficits associated with the disease.
Galantamine is a medication that has been approved by the FDA for the treatment of mild to moderate Alzheimer's disease. Both animal and human models have shown that galantamine can enhance learning and memory. Case reports and preliminary research have suggested that galantamine is an effective adjunctive treatment for schizophrenia, improving both cognition and negative symptoms. Improvements in functioning require that gains in cognition be maintained long enough to allow for the acquisition and application of new skills and behaviors.
Thus, this nine month, open label study assessed the efficacy of galantamine, dosed at 4-12 mg/twice a day, for the treatment of functional impairments in individuals, ages 18-60, with schizophrenia and schizoaffective disorder. The primary outcome measures were changes from baseline to end of study in scores on the Independent Living Scale (ILS) and the Quality of Life Scale (QLS). Secondary outcome measures included assessments of symptoms, cognition, side effects, and movement disorders.
Twenty-one subjects signed informed consent and fourteen subjects were initiated on medication. Six subjects completed the study. As per a priori plan, those subjects (n = 8) who were treated with study medication for at least four months were included in the analyses of treatment outcomes. Our findings regarding the efficacy of galantamine for functional outcomes, including activities of daily living and quality of life, did not support our hypothesis that long-term treatment with galantamine would yield improvements in these domains in patients with schizophrenia spectrum disorders. In fact, in the current study, we did not observe any anticipated improvements in cognition. In addition, we did not observe any anticipated improvements in symptoms, specifically negative symptoms.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00232349
|United States, Washington|
|VA Puget Sound Health Care System, American Lake Division|
|Tacoma, Washington, United States, 98493|
|Principal Investigator:||Andre Tapp, M.D.||VA Puget Sound Health Care System, Tacoma and Seattle, WA and University of Washington, Department of Psychiatry and Behavioral Sciences, Seattle, WA|