Treatment of Neuroleptic Induced Acute Akathisia With Trazodone

Phase 4

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Placebo; Drug: Trazodone

• Registration Number: NCT00659919
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-11
• Primary Completion: 2003-12
• Study Completion: 2003-12
• Study First Submitted: 2008-04-16
• Study First Submitted QC: 2008-04-16
• Study First Posted: 2008-04-17
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-15
• Last Update Posted: 2008-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	The patients in this arm received placebo
Trazodone	Trazodone	The patients on this arm received Trazodone for 3 consecutive days

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Beer Yaakov MHC; 🇮🇱 Beer Yaacov, Israel