Open-Label Duloxetine Monotherapy in the Treatment of Posttraumatic Stress Disorder

NCT00583193 | Unknown Phase 3 DMC

• 1 other identifier: F1J-US-X024
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Post Traumatic Stress Disorder; Duloxetine; Antidepressants

Outcome Measures

Primary Outcomes (1)

• PTSD Symptoms will be assessed by the Clinician-Administered PTSD Scale for DSM-IV (CAPS)

  Performed at baseline, weeks 1, 2, 4, 8, & 12

Secondary Outcomes (1)

• Visual Analog Scale for Pain (VAS)

  Baseline, weeks 1, 2, 4, 8, & 12

Study Arms (1)

1

OTHER

Open-label Study

Drug: Duloxetine hydrochloride

Interventions

Duloxetine hydrochloride DRUG

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.

Also known as: Cymbalta

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Canive, Jose M., M.D.: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

New Mexico VA Health Care System

Albuquerque, New Mexico, 87108, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jose M Canive, M.D.

  New Mexico VA Healthcare System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lawrence A Calais, R.N.

CONTACT

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

Jose M Canive, M.D.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 31, 2007
• Study Start: December 1, 2005
• Study Completion: June 1, 2008
• Last Updated: December 31, 2007

Record last verified: 2007-12

Locations

US (1)