Treatment of Neuroleptic Induced Acute Akathisia With Trazodone

This study has been completed.

Sponsor:

Information provided by:

BeerYaakov Mental Health Center

ClinicalTrials.gov Identifier:

NCT00659919

First received: April 16, 2008

Last updated: June 15, 2008

Last verified: June 2008

History of Changes

Tracking Information
First Received Date ^ICMJE	April 16, 2008
Last Updated Date	June 15, 2008
Start Date ^ICMJE	November 2000
Primary Completion Date	December 2003 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 17, 2008)	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 ]
Original Primary Outcome Measures ^ICMJE (submitted: April 16, 2008)	BARS Akathisia rating scale, PANSS, HAM-D, HAM-A, CGI, SANS [ Designated as safety issue: Yes ]
Change History	Complete list of historical versions of study NCT00659919 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Treatment of Neuroleptic Induced Acute Akathisia With Trazodone
Official Title ^ICMJE	Not Provided
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Schizophrenia
Intervention ^ICMJE	Drug: Placebo Drug: Trazodone
Study Arm (s)	Placebo Comparator: Placebo The patients in this arm received placebo Intervention: Drug: Placebo Active Comparator: Trazodone The patients on this arm received Trazodone for 3 consecutive days Intervention: Drug: Trazodone
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	13
Completion Date	December 2003
Primary Completion Date	December 2003 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Israel

Administrative Information
NCT Number ^ICMJE	NCT00659919
Other Study ID Numbers ^ICMJE	Trazodone-60CTIL
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	BeerYaakov Mental Health Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	BeerYaakov Mental Health Center
Verification Date	June 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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