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Sponsors and Collaborators: |
Beersheva Mental Health Center Stanley Medical Research Institute |
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Information provided by: | Beersheva Mental Health Center |
ClinicalTrials.gov Identifier: | NCT00190008 |
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 |
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Tardive Dyskinesia |
Drug: piracetam |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment |
Official Title: | Therapeutic Use of Piracetam for Treatment of Patients Suffering From Tardive Dyskinesia: a Double Blind, Placebo-Controlled Crossover Study |
Estimated Enrollment: | 40 |
Study Start Date: | August 2003 |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Israel | |
Beersheva Mental Health Center | |
Beersheva, Israel |
Principal Investigator: | Vladimir Lerner, MD, PhD | Ben-Gurion University of the Negev |
Principal Investigator: | Igor Libov, MD | Beersheva Mental Health Center |
Study ID Numbers: | BMHC-3529 |
Study First Received: | September 11, 2005 |
Last Updated: | September 24, 2007 |
ClinicalTrials.gov Identifier: | NCT00190008 |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
tardive dyskinesia piracetam |
Signs and Symptoms Movement Disorders Piracetam Neurologic Manifestations |
Central Nervous System Diseases Dyskinesias Tardive dyskinesia Oral facial dyskinesia |
Nootropic Agents Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases |
Central Nervous System Agents Protective Agents Neuroprotective Agents Pharmacologic Actions |