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Piracetam for Treatment Tardive Dyskinesia

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ClinicalTrials.gov Identifier: NCT00190008
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : November 25, 2009
Stanley Medical Research Institute
Information provided by:
Beersheva Mental Health Center

Brief Summary:

The mechanism involved in the development of tardive dyskinesia (TD) is complicated. It now seems that several neurotransmitter systems may be affected, including dopaminergic, noradrenergic, gamma-amino-butyric acid (GABA) ergic, cholinergic and peptidergic pathways.

Piracetam (2-oxo-pyrrolidone) is a nootropic drug structurally related to GABA. It has been used clinically to treat a wide range of diseases and conditions, mainly in treatment of organic brain syndrome, myoclonus, memory impairment, post-concussional syndrome, vertigo, alcohol withdrawal, cerebrovascular insufficiency, hypoxia, intoxications of different origins or mechanic brain injures. Piracetam is cerebral homeostatic normalizer, neuroprotectant, cerebral metabolic enhancer and brain integrative agent. It enhances brain energy, especially under deficit condition: hypoxia, chemical toxicity or impaired cerebral microcirculation; preserve, protect and enhance synaptic membrane and receptor structure and plasticity. It has various effects on glutamate neurotransmission on micromolar levels piracetam potentiates potassium-induced release of glutamate from hippocampal nerves. It is an oxidant agent and may be useful for treatment TD. Piracetam is among the toxicologically safest drugs ever developed even in mega doses.

Data derived from some clinical reports have suggested that piracetam can improve symptoms and is effective agent for treatment of different movement disorders including acute neuroleptic induced extrapyramidal symptoms and TD. The doses that used for TD treatment varied from 800 mg/day to 24000 mg/day. According to these findings the symptoms of TD disappeared in the period of 3-7 days.

To date there was only one double-blind crossover study regarding use of piracetam for treatment TD that was conducted almost 20 years ago. The findings of this study were impressive, but to our knowledge nobody reproduced these results.

Condition or disease Intervention/treatment Phase
Tardive Dyskinesia Drug: piracetam Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Therapeutic Use of Piracetam for Treatment of Patients Suffering From Tardive Dyskinesia: a Double Blind, Placebo-Controlled Crossover Study
Study Start Date : August 2003

Primary Outcome Measures :
  1. Extrapyramidal Symptom Rating Scale

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age 18-75
  • DSM-IV diagnosis of tardive dyskinesia
  • stable psychotropic regimen of a month prior to entry
  • duration of TD for at least one year
  • hospitalization at our Center

Exclusion Criteria:

  • family history of Huntington's disease
  • drug or alcohol abuse
  • concurrent medial illness or neurological disorder that may have contributed to the diagnosis of TD

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00190008

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Beersheva Mental Health Center
Beersheva, Israel
Sponsors and Collaborators
Beersheva Mental Health Center
Stanley Medical Research Institute
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Principal Investigator: Vladimir Lerner, MD, PhD Ben-Gurion University of the Negev
Principal Investigator: Igor Libov, MD Beersheva Mental Health Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00190008    
Other Study ID Numbers: BMHC-3529
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: November 25, 2009
Last Verified: November 2009
Keywords provided by Beersheva Mental Health Center:
tardive dyskinesia
Additional relevant MeSH terms:
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Tardive Dyskinesia
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Dyskinesia, Drug-Induced
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Nootropic Agents