NCT00161044

Brief Summary

The purpose of this study is to see if galantamine is an effective agent for the treatment of the cognitive abnormalities, negative symptoms, and /or behavioral impairments seen in schizophrenia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

March 17, 2022

Status Verified

March 1, 2022

First QC Date

September 8, 2005

Last Update Submit

March 1, 2022

Conditions

Chronic Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • This trial is an exploratory open-label trial; thus, several outcome measures are employed in order to detect possible therapeutic effects in the negative symptom domain of psychopathology

Interventions

GalantamineDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Fulfills DSM-IV criteria for schizophrenia.
  • Unable to achieve competitive employment status within the past five years.
  • Unable to live independently in the community.
  • Maintained on a stable regimen of antipsychotic medication for at least two weeks prior to enrollment.

You may not qualify if:

  • History of significant hepatic, renal, pulmonary, endocrine, active peptic ulcer disease or cardiovascular disease.
  • History of seizure disorder and/or head injury.
  • Co-morbid substance use/abuse disorder.
  • Received an investigational medication within the previous month.
  • Due to the risk of adverse effects on fetal development: women with any risk of becoming pregnant will be excluded from this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maryland Psychiatric Research Center

Catonsville, Maryland, 21228, United States

Location

MeSH Terms

Interventions

Galantamine

Intervention Hierarchy (Ancestors)

Amaryllidaceae AlkaloidsAlkaloidsHeterocyclic CompoundsBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Matthew Nelson, Pharm.D.

    MPRC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

September 1, 2004

Study Completion

September 1, 2005

Last Updated

March 17, 2022

Record last verified: 2022-03

Locations

US(1)