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

Primary Purpose

Posttraumatic Stress Disorders

Status

Unknown status

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Duloxetine hydrochloride

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorders focused on measuring Post Traumatic Stress Disorder, Duloxetine, Antidepressants

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

New Mexico VA Health Care SystemRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm Description

Open-label Study

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Visual Analog Scale for Pain (VAS)

Full Information

NCT ID

NCT00583193

First Posted

December 20, 2007

Last Updated

December 20, 2007

Sponsor

Canive, Jose M., M.D.

Collaborators

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00583193

Brief Title

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

Official Title

A Study of the Effectiveness and Tolerability of Duloxetine (Cymbalta) in the Treatment of PTSD.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2007

Overall Recruitment Status

Unknown status

Study Start Date

December 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Canive, Jose M., M.D.

Collaborators

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

Detailed Description

Duloxetine has established efficacy for treatment of major depression, generalized anxiety disorder and diabetic peripheral neuropathic pain. Chronic PTSD is often treated with antidepressants, in fact there are only two FDA-approved treatments for PTSD. Yet many chronic PTSD patients, especially male combat veterans, have a limited response to antidepressant treatment (Baker et al, 1995; Cañive et al, 1998; Hertzsberg et al 2000) and new pharmacotherapies should be investigated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Posttraumatic Stress Disorders

Keywords

Post Traumatic Stress Disorder, Duloxetine, Antidepressants

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Other

Arm Description

Open-label Study

Intervention Type

Drug

Intervention Name(s)

Duloxetine hydrochloride

Other Intervention Name(s)

Cymbalta

Intervention Description

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 Information:

Title

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

Secondary Outcome Measure Information:

Title

Visual Analog Scale for Pain (VAS)

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lawrence A Calais, R.N.

Phone

505-265-1711

Ext

2677

lawrence.calais@va.gov

First Name & Middle Initial & Last Name or Official Title & Degree

Jose M Canive, M.D.

Phone

505-265-1711

Ext

4935

jose.canive@va.gov

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jose M Canive, M.D.

Organizational Affiliation

New Mexico VA Healthcare System

Official's Role

Principal Investigator

Facility Information:

Facility Name

New Mexico VA Health Care System

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87108

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jose M Canive, M.D.

12. IPD Sharing Statement

Learn more about this trial

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

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