Piracetam for Treatment Tardive Dyskinesia

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by:
Beersheva Mental Health Center
ClinicalTrials.gov Identifier:
NCT00190008
First received: September 11, 2005
Last updated: November 23, 2009
Last verified: November 2009
  Purpose

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 Intervention Phase
Tardive Dyskinesia
Drug: piracetam
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Therapeutic Use of Piracetam for Treatment of Patients Suffering From Tardive Dyskinesia: a Double Blind, Placebo-Controlled Crossover Study

Resource links provided by NLM:


Further study details as provided by Beersheva Mental Health Center:

Primary Outcome Measures:
  • Extrapyramidal Symptom Rating Scale

Estimated Enrollment: 40
Study Start Date: August 2003
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00190008

Locations
Israel
Beersheva Mental Health Center
Beersheva, Israel
Sponsors and Collaborators
Beersheva Mental Health Center
Stanley Medical Research Institute
Investigators
Principal Investigator: Vladimir Lerner, MD, PhD Ben-Gurion University of the Negev
Principal Investigator: Igor Libov, MD Beersheva Mental Health Center
  More Information

No publications provided by Beersheva Mental Health Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00190008     History of Changes
Other Study ID Numbers: BMHC-3529
Study First Received: September 11, 2005
Last Updated: November 23, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Beersheva Mental Health Center:
tardive dyskinesia
piracetam

Additional relevant MeSH terms:
Dyskinesias
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Piracetam
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Nootropic Agents

ClinicalTrials.gov processed this record on August 21, 2014