Efficacy Study of Galantamine for Cognitive Impairments in Schizophrenia

NCT00176423 | Completed Phase 4 Results DMC

• 1 other identifier: 01T-411
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine whether adjunctive galantamine is effective in the treatment of cognitive impairments in patients with schizophrenia.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

schizophrenia; acetylcholine; cognitive impairments; attention; processing speed; sensory gating; eye-tracking

Outcome Measures

Primary Outcomes (1)

• Overall Cognitive Improvement Z-score

  Participants were administered an eight-test neuropsychological test battery at baseline and end-of-study. The battery included the following tests: working memory: WAIS-III Letter-Number Sequencing and Brief Assessment of Cognition in Schizophrenia Number Sequencing; verbal memory: California Verbal Learning Test (CVLT); visual memory: Brief Visuospatial Memory Test (BVMT); motor speed: Grooved Pegboard; processing speed: WAIS-III Digit Symbol and WAIS-III Symbol Search; and the Gordon Diagnostic System CPT. Alternate forms of the CVLT and BVMT were used for the two test occasions. For each neuropsychological test, participant scores were converted to z-scores: z = (score - baseline mean)/baseline SD. For the primary outcome measure, an overall composite z-score was computed from the average of the individual test z-scores. A positive z-score would reflect better performance compared to baseline; a negative z-score would reflect worse performance compared to baseline.

  12 weeks

Secondary Outcomes (3)

• ECG Changes From Baseline to 12 Weeks.

  12 weeks

• Simpson Angus Scale (SAS) Total Score

  12 weeks (Week 12 - Week 0)

• Abnormal Involuntary Movement Scale (AIMS)

  12 weeks (Week 12 - Week 0)

Study Arms (2)

galantamine

EXPERIMENTAL

galantamine, 24mgs, p.o., qday

Drug: galantamine

placebo

PLACEBO COMPARATOR

placebo, 3 tablets, p.o., qday

Drug: galantamine

Interventions

galantamine DRUG

see arm/group description

galantamine; placebo

Eligibility Criteria

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

You may qualify if:

• DSM-IV diagnosis of either schizophrenia or schizoaffective disorder.
• Males and females
• Age: 18 and 60
• Caucasian or Non-Caucasian
• Subjects will be currently treated with one of the following new generation antipsychotics: olanzapine, risperidone, quetiapine, ziprasidone, or aripiprazole.
• Subjects will meet a priori criteria for cognitive impairment severity. The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) will be used to determine the level of cognitive impairment. Patients will meet entry criteria if they have a RBANS total score of 90 or less (one standard deviation below the normal control mean).

You may not qualify if:

• History of an organic brain disease
• History of DSM-IV alcohol or substance abuse (within the last month), or DSM-IV alcohol or substance dependence (within the last six months).
• Pregnant women and women taking oral contraceptives (because of the theoretical risk of breakthrough ovulation).
• Current treatment with galantamine or other acetylcholinesterase inhibitor (e.g. donepezil)
• History of a second or third degree atrioventricular (AV) block.
• Persons with chronic medical conditions, which are unstable.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Stanley Medical Research Institute: collaborator
• Ortho-McNeil Neurologics, Inc.: collaborator

Study Sites (1)

Maryland Psychiatric Research Center

Baltimore, Maryland, 21228, United States

Location

Related Publications (1)

• Buchanan RW, Conley RR, Dickinson D, Ball MP, Feldman S, Gold JM, McMahon RP. Galantamine for the treatment of cognitive impairments in people with schizophrenia. Am J Psychiatry. 2008 Jan;165(1):82-9. doi: 10.1176/appi.ajp.2007.07050724. Epub 2007 Nov 6.

  PMID: 17986678 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Cognitive Dysfunction

Interventions

Galantamine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Robert W. Buchanan, M.D.
• Organization: Maryland Psychiatric Research Center

rbuchanan@som.umaryland.edu

410-402-7876

Study Officials

• Robert W Buchanan, M.D.

  University of Maryland Baltimore School of Medicine, Maryland Psychiatric Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: May 1, 2002
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: December 16, 2020
• Results First Posted: December 16, 2020

Record last verified: 2020-10

Locations

US (1)