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Treatment of Neuroleptic Induced Acute Akathisia With Trazodone

NCT ID: NCT00659919

Last Updated: 2008-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-11-30

Study Completion Date

2003-12-31

Brief Summary

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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

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

The patients in this arm received placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Trazodone

The patients on this arm received Trazodone for 3 consecutive days

Group Type ACTIVE_COMPARATOR

Trazodone

Intervention Type DRUG

Interventions

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Placebo

Intervention Type DRUG

Trazodone

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BeerYaakov Mental Health Center

OTHER_GOV

Sponsor Role lead

Locations

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Beer Yaakov MHC

Beer Yaacov, , Israel

Site Status

Countries

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Israel

Other Identifiers

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Trazodone-60CTIL

Identifier Type: -

Identifier Source: org_study_id