Treatment of Neuroleptic Induced Acute Akathisia With Trazodone

• Sponsor: BeerYaakov Mental Health Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00659919
• Collaborator: (none)
• Enrollment: 13
• Location: 1
• Arms: 2
• Duration (Months): 37
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Placebo; Drug: Trazodone	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Nov 1, 2000
• Actual Primary Completion Date: Dec 1, 2003
• Actual Study Completion Date: Dec 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. 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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Beer Yaakov MHC	Beer Yaacov		Israel	70350

Sponsors and Collaborators

• BeerYaakov Mental Health Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00659919
• Other Study ID Numbers: Trazodone-60CTIL
• First Posted: Apr 17, 2008
• Last Update Posted: Jun 17, 2008
• Last Verified: Jun 1, 2008

• Additional relevant MeSH terms: Schizophrenia; Trazodone

Study Results

No Results Posted as of Jun 17, 2008