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Treatment of Neuroleptic Induced Acute Akathisia With Trazodone

B

BeerYaakov Mental Health Center

Status and phase

Completed
Phase 4

Conditions

Schizophrenia

Treatments

Drug: Placebo
Drug: Trazodone

Study type

Interventional

Funder types

Other

Identifiers

NCT00659919
Trazodone-60CTIL

Details and patient eligibility

About

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.

Enrollment

13 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

13 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
The patients in this arm received placebo
Treatment:
Drug: Placebo
Trazodone
Active Comparator group
Description:
The patients on this arm received Trazodone for 3 consecutive days
Treatment:
Drug: Trazodone

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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