Recruiting
Phase 3

Duloxetine

Sponsor:

Canive, Jose M., M.D.

Code:

NCT00583193

Conditions

Posttraumatic Stress Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Duloxetine hydrochloride

Study Details

Brief summary:

The purpose of this study is to determine whether Duloxetine (Cymbalta®) is an effective treatment in reducing the symptoms of Posttraumatic Stress Disorder (PTSD).

Conditions

Posttraumatic Stress Disorders

Study ID

NCT00583193

Start date

Dec, 2005

Status verified date

Dec, 2007

Completion date

Jun, 2008

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Male or female patients ages 18 or older of any ethnic background meeting DSM-IV criteria for PTSD
  • Score of at least 60 on the CAPS-SX at baseline
  • Competent to give informed consent
  • If female, patient should be using a medically approved contraceptive, or not otherwise be of childbearing potential
  • Patients who have not taken medications or herbal remedies for a psychiatric indication within one week prior to the baseline visit (treatment phase); two weeks prior in the case of fluoxetine or in the case of an MAOI
  • Other medications, if any, must have been kept stable for at least one month prior to the baseline visit

Exclusion Criteria:

  • Known hypersensitivity to duloxetine or any of the inactive ingredients
  • Females who are pregnant or breastfeeding
  • Use of antipsychotics, antidepressants, or benzodiazepines (except for short-term use during study as specified in Concomitant Medications section) within one week prior to the baseline visit and throughout the study period
  • Use of fluoxetine or an MAOI within two weeks
  • Concomitant use of narrow therapeutic index medications or medications that are likely to have a clinically significant drug interaction with duloxetine
  • Medical conditions that may prevent safe administration of duloxetine including end stage renal disease, clinically significant renal impairment (CrCl <30 mL/min), hepatic insufficiency, cardiac disease, or pulmonary disease
  • Patients with uncontrolled narrow-angle glaucoma
  • Alcohol or drug abuse or dependence within three months of study entry as defined by DSM-IV criteria
  • Alcohol use may not exceed 12 drinks per week or 5 drinks per drinking episode during the course of the study.
  • A current or past history of bipolar disorder, schizophrenia, schizoaffective disorder or other psychotic disorder
  • Suicidal or homicidal ideation or other clinically significant dangerous behavior
  • Currently seeking compensation or increase in compensation for the effects of the trauma
  • Initiation or change in psychotherapy within 3 months of study entry

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: 1

Open-label Study

Interventions

Duloxetine hydrochloride

Start 30 mg Q.D. for 7 days, then increased to 60 mg Q.D. @ the week 1 visit. Thereafter, dose may be increased or decreased by 30 mg increments based on tolerability and efficacy between a dosage range of 60 to 120 mg.

Primary outcome measure

  • PTSD Symptoms will be assessed by the Clinician-Administered PTSD Scale for DSM-IV (CAPS) [ Time Frame: Performed at baseline, weeks 1, 2, 4, 8, & 12 ]

Central Contacts and Locations

Central contacts

Lawrence A Calais, R.N.

505-265-1711lawrence.calais@va.gov

Jose M Canive, M.D.

505-265-1711jose.canive@va.gov

Locations

New Mexico VA Health Care System

Recruiting

Albuquerque, New Mexico, United States, 87108

Principal Investigator:

Jose M Canive, M.D.

More Information

Sponsor

Canive, Jose M., M.D.

Last update posted

Dec 31, 2007

Last verified

Dec, 2007

Keywords

  • Post Traumatic Stress Disorder
  • Duloxetine
  • Antidepressants

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Canive, Jose M., M.D. on 2007-12-31.