Treatment of Neuroleptic Induced Acute Akathisia With Trazodone - Tabular View

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
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Treatment of Neuroleptic Induced Acute Akathisia With Trazodone
Official Title ^ICMJE
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
Study Phase	Phase IV
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Condition ^ICMJE	Schizophrenia
Intervention ^ICMJE	Drug: Placebo Drug: Trazodone
Study Arms / Comparison Groups	Placebo Comparator: The patients in this arm received placebo Active Comparator: The patients on this arm received Trazodone for 3 consecutive days
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) 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 ID ^ICMJE	NCT00659919
Responsible Party
Study ID Numbers ^ICMJE	Trazodone-60CTIL
Study Sponsor ^ICMJE	BeerYaakov Mental Health Center
Collaborators ^ICMJE
Investigators ^ICMJE
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