Back to resultsTreatment of Neuroleptic Induced Acute Akathisia With Trazodone
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Placebo
Trazodone
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility 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
Sites / Locations
- Beer Yaakov MHC
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Trazodone
Arm Description
The patients in this arm received placebo
The patients on this arm received Trazodone for 3 consecutive days
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00659919
First Posted
April 16, 2008
Last Updated
June 15, 2008
Sponsor
BeerYaakov Mental Health Center
1. Study Identification
Unique Protocol Identification Number
NCT00659919
Brief Title
Treatment of Neuroleptic Induced Acute Akathisia With Trazodone
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
November 2000 (undefined)
Primary Completion Date
December 2003 (Actual)
Study Completion Date
December 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
BeerYaakov Mental Health Center
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The patients in this arm received placebo
Arm Title
Trazodone
Arm Type
Active Comparator
Arm Description
The patients on this arm received Trazodone for 3 consecutive days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Trazodone
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Beer Yaakov MHC
City
Beer Yaacov
ZIP/Postal Code
70350
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Treatment of Neuroleptic Induced Acute Akathisia With Trazodone
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