Treatment of Neuroleptic Induced Acute Akathisia With Trazodone

This study has been completed.

First Received on April 16, 2008. Last Updated on 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:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Anxiety 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 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

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

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

Additional relevant MeSH terms:

Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Trazodone
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents

Therapeutic Uses
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents

ClinicalTrials.gov processed this record on February 12, 2012