Posttraumatic Stress Disorders | Open-Label Duloxetine Monotherapy in the Treatment of Posttraumatic Stress Disorder
Posttraumatic Stress Disorders research study
What is the primary objective of this study?
The purpose of this study is to determine whether Duloxetine (Cymbalta®) is an effective treatment in reducing the symptoms of Posttraumatic Stress Disorder (PTSD).
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Posttraumatic Stress Disorders
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Duloxetine hydrochlorideStart 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.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: December 2005
Completed Date: June 2008
Phase: Phase 3
Primary Outcome: PTSD Symptoms will be assessed by the Clinician-Administered PTSD Scale for DSM-IV (CAPS)
Secondary Outcome: Visual Analog Scale for Pain (VAS)
Study sponsors, principal investigator, and references
Principal Investigator: Jose M Canive, M.D.
Lead Sponsor: Canive, Jose M., M.D.
Collaborator: Eli Lilly and Company