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Treatment of Neuroleptic Induced Acute Akathisia With Trazodone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00659919
Recruitment Status : Completed
First Posted : April 17, 2008
Last Update Posted : June 17, 2008
Information provided by:
BeerYaakov Mental Health Center

Brief Summary:
Administration of trazodone for the treatment of neuroleptic induced acute akathisia in a cross-over fashion of 6 days duration. 3 days of placebo and 3 days of trazodone.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Placebo Drug: Trazodone Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : November 2000
Actual Primary Completion Date : December 2003
Actual Study Completion Date : December 2003

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo
The patients in this arm received placebo
Drug: Placebo
Active Comparator: Trazodone
The patients on this arm received Trazodone for 3 consecutive days
Drug: Trazodone

Primary Outcome Measures :
  1. Barnes Akathisia rating scale, Positive and Negative syndrome scale, Hamilton Depression Rating Scale, Hamilton Anxiety Scale, Clinical Global Impression, Scale for the Assessment of Negative Symptoms

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with akathisia according to DSM-IV criteria at least mild akathisia.

Exclusion Criteria:

  • Change of pharmacologic regimen 7 days prior to study entry
  • Significant systemic disease
  • The presence of chronic akathisia
  • Patients unable to cooperate

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 identifier (NCT number): NCT00659919

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Beer Yaakov MHC
Beer Yaacov, Israel, 70350
Sponsors and Collaborators
BeerYaakov Mental Health Center

Layout table for additonal information Identifier: NCT00659919     History of Changes
Other Study ID Numbers: Trazodone-60CTIL
First Posted: April 17, 2008    Key Record Dates
Last Update Posted: June 17, 2008
Last Verified: June 2008
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents