Treatment of Neuroleptic Induced Acute Akathisia With Trazodone

This study has been completed.

First Received: April 16, 2008 Last Updated: June 15, 2008 History of Changes

Sponsor:	BeerYaakov Mental Health Center
Information provided by:	BeerYaakov Mental Health Center
ClinicalTrials.gov Identifier:	NCT00659919

Purpose

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	Intervention	Phase
Schizophrenia	Drug: Placebo Drug: Trazodone	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Trazodone Trazodone hydrochloride

U.S. FDA Resources

Further study details as provided by BeerYaakov Mental Health Center:

Primary Outcome Measures:

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 [ Designated as safety issue: Yes ]

Enrollment:	13
Study Start Date:	November 2000
Study Completion Date:	December 2003
Primary Completion Date:	December 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo: Placebo Comparator The patients in this arm received placebo	Drug: Placebo
Trazodone: Active Comparator The patients on this arm received Trazodone for 3 consecutive days	Drug: Trazodone

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659919

Locations

Israel
Beer Yaakov MHC
Beer Yaacov, Israel, 70350

Sponsors and Collaborators

BeerYaakov Mental Health Center

More Information

No publications provided

Study ID Numbers:	Trazodone-60CTIL
Study First Received:	April 16, 2008
Last Updated:	June 15, 2008
ClinicalTrials.gov Identifier:	NCT00659919 History of Changes
Health Authority:	Israel: Ministry of Health

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Trazodone
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Serotonin Uptake Inhibitors
Pharmacologic Actions

Schizophrenia
Serotonin Agents
Mental Disorders
Therapeutic Uses
Anti-Anxiety Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 11, 2009