Efficacy of Galantamine to Treat Schizophrenia

NCT00232349 | Terminated Phase 4 DMC

• 2 other identifiers: TA1 28GAL-EMR-4009
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Psychotic Disorder

Keywords

schizophrenia; galantamine; cholinesterase inhibitors; quality of life; cognition

Outcome Measures

Primary Outcomes (2)

• score on a measure of quality of life

  after 9 months treatment

• score on a measure of independent living skills

  after 9 months treatment

Secondary Outcomes (3)

• score on a measure of psychopathology

  after 9 months treatment

• score on a measure of negative symptoms

  after 9 months treatment

• score on a neurocognitive battery

  after 9 months treatment

Study Arms (1)

Intervention group

EXPERIMENTAL

All subjects enrolled in study are in the intervention group.

Drug: galantamine

Interventions

galantamine DRUG

open label galantamine, dosed at 4-12 mg/b.i.d., with a target dose of 12 mg/b.i.d.

Also known as: Razadyne, Reminyl

Intervention group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-60
• Able to provide informed, written consent
• Treatment for schizophrenia or schizoaffective disorder for 5 or more years
• Diagnosis of schizophrenia or schizoaffective disorder
• Psychiatrically stable as evidenced by no hospitalizations and no changes in psychiatric medications (with the exception of dosage adjustments and the prescription of adjunctive treatments for sleep disturbance or anxiety) within the prior 3 months, and as confirmed by clinical interview during the screening phase
• Total score \> 60 baseline on The Positive and Negative Syndrome Scale (PANSS)
• Score \> 3 on at least one of the five subscales of the SANS
• Non-Kraepelinian schizophrenia, as defined by the ability to independently provide for at least one domain of basic needs
• Females must be of non-child bearing potential or on appropriate contraceptive and not breast-feeding
• Females must have a negative serum beta HCG at screening
• Clinical laboratory values within normal limits, as defined in study protocol, or abnormalities considered not clinically significant by the investigator

You may not qualify if:

• Kraepelinian schizophrenia, as defined by dependency on others for the provision of all basic needs (including shopping, food preparation, household chores, and transportation);
• DSM-IV criteria for substance dependence (excluding nicotine and caffeine), as determined by SCID and chart review, during the 90 days prior to screening;
• Patients judged by the investigator as being at significant risk of suicide, violent behavior, or homicide;
• Concurrent participation or participation within the prior 30 days in any study involving investigational medications;
• Females who are pregnant or lactating;
• Neurodegenerative disorders such as Alzheimer's disease and other dementias, Parkinson's disease, Pick's disease, and Huntington's chorea;
• A history of significant cerebrovascular event yielding a physical or neurological deficit likely to confound the assessment of the subject's functioning;
• A history of significant head trauma, defined as head trauma resulting in neurological or cognitive sequelae;
• A known personal history of seizure disorder;
• A known sensitivity to cholinesterase inhibitors, choline agonists, or similar agents;
• Patients who are known to be HIV positive;
• Evidence of clinically significant, active gastrointestinal, hepatic, pulmonary, endocrine, renal, or cardiovascular system disease;
• Active or clinically significant conditions affecting absorption, distribution or metabolism of the study medication (e.g. inflammatory bowel disease or gastric or duodenal ulcers);
• Clinically significant urinary outflow obstruction;
• Patients with untreated thyroid disease;

Sponsors & Collaborators

• Seattle Institute for Biomedical and Clinical Research: lead

Study Sites (1)

VA Puget Sound Health Care System, American Lake Division

Tacoma, Washington, 98493, United States

Location

Related Publications (1)

• Allen TB, McEvoy JP. Galantamine for treatment-resistant schizophrenia. Am J Psychiatry. 2002 Jul;159(7):1244-5. doi: 10.1176/appi.ajp.159.7.1244. No abstract available.

  PMID: 12091212 BACKGROUND

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

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 30, 2005
• First Posted: October 4, 2005
• Study Start: February 1, 2005
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: July 31, 2008

Record last verified: 2008-07

Locations

US (1)