NCT00164242

Brief Summary

Tardive dyskinesia (TD), a form of movement disorder, remains a problem for some patients who received antipsychotic medications. Increasing evidence suggests that TD may result from antipsychotic-induced dysfunction in striatal cholinergic neurons. To test whether cholinesterase inhibitors compensate for diminished cholinergic activity underlying TD, we conducted a 30-week randomized, double-blind, placebo-controlled crossover study of galantamine in 36 patients with TD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2002

Typical duration for phase_4

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

January 1, 2002

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
Last Updated

September 14, 2005

Status Verified

September 1, 2005

First QC Date

September 9, 2005

Last Update Submit

September 9, 2005

Conditions

Tardive Dyskinesia

Keywords

Tardive dyskinesiaGalantamineCholinesterase inhibitors

Outcome Measures

Primary Outcomes (1)

  • Change in Abnormal Involuntary Movement scale at 3 months.

Secondary Outcomes (1)

  • Change in Simpson-Angus and Barnes Akathisia scales at 3 moths.

Interventions

GalantamineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of tardive dyskinesia lasting at least 3 months
  • Treatment with antipsychotic drugs at least for 3 months
  • years old or older

You may not qualify if:

  • Significant active medical illness
  • Allergy to galantamine
  • Pregnancy
  • Drug or alcohol dependence
  • Necessary use of anticholinergics or vitamin E

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Philadelphia VA Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

  • Caroff SN, Campbell EC, Havey J, Sullivan KA, Mann SC, Gallop R. Treatment of tardive dyskinesia with donepezil: a pilot study. J Clin Psychiatry. 2001 Oct;62(10):772-5. doi: 10.4088/jcp.v62n1004.

    PMID: 11816865BACKGROUND

  • Caroff SN, Walker P, Campbell C, Lorry A, Petro C, Lynch K, Gallop R. Treatment of tardive dyskinesia with galantamine: a randomized controlled crossover trial. J Clin Psychiatry. 2007 Mar;68(3):410-5. doi: 10.4088/jcp.v68n0309.

    PMID: 17388711DERIVED

MeSH Terms

Conditions

Tardive Dyskinesia

Interventions

Galantamine

Condition Hierarchy (Ancestors)

Dyskinesia, Drug-InducedDyskinesiasMovement DisordersCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Stanley N Caroff, MD

    Corporal Michael J. Crescenz VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDIV

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

January 1, 2002

Study Completion

October 1, 2004

Last Updated

September 14, 2005

Record last verified: 2005-09

Locations

US(1)