Treatment of Tardive Dyskinesia With Galantamine

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Brief Title

Treatment of Tardive Dyskinesia With Galantamine

Official Title

Treatment of Tardive Dyskinesia With Galantamine

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.
    

Detailed Description

      BACKGROUND: Tardive dyskinesia (TD) is an infrequent but important complication of treatment
      with antipsychotic medications. Although newer antipsychotics may be less likely to cause TD,
      it still occurs among some mentally ill patients previously treated with typical
      antipsychotics. Although usually mild, TD may be more troublesome in some patients. There is
      no proven curative or suppressive treatment that is effective in all patients. Suppressive
      treatment with cholinergic agents derives from a hypothesized balance between dopaminergic
      and cholinergic neurotransmission in the extrapyramidal system. Although previous trials of
      cholinergic precursors have been unsuccessful in treating TD, their effect on central
      cholinergic neurotransmission remains uncertain in view of evidence of damage to striatal
      cholinergic neurons in patients with TD. In contrast, the recent development of
      cholinesterase inhibitors that are effective in modifying the central cholinergic deficit in
      Alzheimer's disease, prompted us to investigate the therapeutic effect of galantamine in
      patients with TD.

      RESEARCH OBJECTIVES: We propose to complete a randomized, double-blind, placebo-controlled
      crossover trial in 36 patients to test; (1) whether galantamine is pharmacologically active
      in suppressing TD; (2) whether doses of 8-24 mg/day are sufficient for improvement; (3)
      whether there are any significant side effects in these patients.

      METHODS: Thirty-six patients with abnormal involuntary movements meeting research criteria
      for TD, who are on stable doses of psychotropic medications, will be randomized to receive
      galantamine alternating with placebo in addition to their standard medications. After 2
      baseline measurements, each patient will undergo 12-week treatment periods of galantamine and
      placebo with a 4-week washout period between treatments. Patients will be evaluated every 2
      weeks throughout the study, using standardized rating scales for TD (AIMS) and other
      extrapyramidal side effects (SIMPSON, BARNES. During the active treatment period, patients
      will receive galantamine 4 mg BID for 4 weeks followed by 8 mg BID for 4 weeks, and 12 mg BID
      for an additional 4 weeks. Placebo-galantamine differences will be examined by repeated
      measures analysis of covariance for a two-period crossover design.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Change in Abnormal Involuntary Movement scale at 3 months.

Secondary Outcome

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

Condition

Tardive Dyskinesia

Intervention

Galantamine


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

36

Start Date

January 2002

Completion Date

October 2004


Eligibility Criteria

        Inclusion Criteria:

          -  Clinical diagnosis of tardive dyskinesia lasting at least 3 months

          -  Treatment with antipsychotic drugs at least for 3 months

          -  18 years old or older

        Exclusion Criteria:

          -  Significant active medical illness

          -  Allergy to galantamine

          -  Pregnancy

          -  Drug or alcohol dependence

          -  Necessary use of anticholinergics or vitamin E
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Stanley N Caroff, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00164242

Organization ID

00347

Secondary IDs

00347


Study Sponsor

Caroff, Stanley N., M.D.

Collaborators

 Ortho-McNeil Neurologics, Inc.

Study Sponsor

Stanley N Caroff, MD, Principal Investigator, Corporal Michael J. Crescenz VA Medical Center


Verification Date

September 2005