NCT00659919

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_4 schizophrenia

Timeline
Completed

Started Nov 2000

Typical duration for phase_4 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2000

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 17, 2008

Completed
Last Updated

June 17, 2008

Status Verified

June 1, 2008

Enrollment Period

3.1 years

First QC Date

April 16, 2008

Last Update Submit

June 15, 2008

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

The patients in this arm received placebo

Drug: Placebo

Trazodone

ACTIVE COMPARATOR

The patients on this arm received Trazodone for 3 consecutive days

Drug: Trazodone

Interventions

PlaceboDRUG
Placebo
TrazodoneDRUG
Trazodone

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with akathisia according to DSM-IV criteria at least mild akathisia.

You may not qualify if:

  • Change of pharmacologic regimen 7 days prior to study entry
  • Significant systemic disease
  • The presence of chronic akathisia
  • Patients unable to cooperate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beer Yaakov MHC

Beer Yaacov, 70350, Israel

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Trazodone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyridonesPyridines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

April 16, 2008

First Posted

April 17, 2008

Study Start

November 1, 2000

Primary Completion

December 1, 2003

Study Completion

December 1, 2003

Last Updated

June 17, 2008

Record last verified: 2008-06

Locations

IL(1)