Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00232349
Status:
TERMINATED
Last Update Posted:
2008-07-31
First Post:
2005-09-30
Brief Title:
Efficacy of Galantamine to Treat Schizophrenia
Sponsor:
Seattle Institute for Biomedical and Clinical Research
Organization:
Seattle Institute for Biomedical and Clinical Research
Study Overview
Official Title:
An Open-Label Trial of Adjunctive Galantamine Maintenance Therapy to Treat Functional Impairments in Chronic Outpatients With Schizophrenia
Status:
TERMINATED
Status Verified Date:
2008-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated due to no apparent benefit
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study was to determine if treatment with adjunctive galantamine is effective in the reduction of functional impairments in patients with schizophrenia and schizoaffective disorder It was hypothesized that adjunctive galantamine would yield clinically significant improvements from baseline to end of study on a measure of quality of life and a measure of independent living skills
Detailed Description:
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 Alzheimers 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 mgtwice 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
Galantamine is a medication that has been approved by the FDA for the treatment of mild to moderate Alzheimers 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 mgtwice 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GAL-EMR-4009 | None | None | None |