A Ten-week, Randomized, Double-blind Study Evaluating the Efficacy of Duloxetine 60 mg Once Daily Versus Placebo in Outpatients With Major Depressive Disorder and Pain (EU-Pain Enriched Study)

Boehringer Ingelheim0 sites327 target enrollmentMay 2005

ConditionsDepressive Disorder, Major

InterventionsDuloxetine Placebo

DrugsDuloxetine Placebo

Overview

Phase: Phase 3
Intervention: Duloxetine
Conditions: Depressive Disorder, Major
Sponsor: Boehringer Ingelheim
Enrollment: 327
Primary Endpoint: Change of 24-hour average pain rated on Brief Pain Inventory-Short Form (BPI-SF) score
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study was to investigate the efficacy of duloxetine versus placebo on pain in outpatients with major depressive disorder (MDD): change in Brief Pain Inventory Short Form (BPI-SF) 24-hour average pain score from baseline over the 8 weeks of treatment

Registry

clinicaltrials.gov

Start Date

May 2005

End Date

May 2006

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female outpatients who meet the criteria for MDD according to the Diagnostic and Statistic Manual of mental disorders, 4th edition (DSM-IV) criteria and confirmed by Mini International Neuropsychiatric Interview (MINI)
•Montgomery-Asberg Depression Rating Scale (MADRS) score ≥20 at screening and baseline (Visits 1 and 2)
•Patients must have had at least one previous episode of depression in their medical history
•Painful physical symptoms (PPS) with a score ≥ 3 on the BPI-SF scale for average pain at screening and baseline
•Patient aged 18 years or older at the screening visit
•CGI-Severity score ≥ 4 at Visits 1 and 2
•Patients willing and able to comply with the scheduled visits, tests and procedures required by the protocol
•Written informed consent obtained at the screening visit, in accordance with Good clinical practice (GCP) and local regulatory requirements, prior to any study procedure

Exclusion Criteria

•Neuro-psychiatric exclusions
•Lack of response of the current episode to 2 or more adequate courses of antidepressant therapy given at a clinically appropriate dose and for a sufficient length of time in the judgement of the investigator
•Any anxiety disorder as a primary diagnosis within the past 6 months (including panic disorder, obsessive-compulsive disorder, posttraumatic stress disorder, generalized anxiety disorder, and social phobia). Note: Specific phobias (i.e. agoraphobia, arachnophobia, etc.) will be allowed
•Any diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders
•Presence of an Axis II disorder which, in the judgement of the investigator, would interfere with compliance with the study protocol
•History of serious suicide attempt or patient judged to be at serious suicidal risk in the opinion of the investigator and / or score \> 2 for question 10 (suicide) of the MADRS
•History of drug dependence, including alcohol or benzodiazepines, according to DSM-IV, in the previous year
•Positive urine screen for drug abuse (cannabis, benzodiazepines, barbiturates, opiates, cocaine, amphetamines)
•Other medical exclusions
•Patients requiring continuous treatment with analgesics (\> step 2 WHO definition) because of chronic pain (\> 6 months)

Arms & Interventions

Duloxetine

Intervention: Duloxetine

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Change of 24-hour average pain rated on Brief Pain Inventory-Short Form (BPI-SF) score

Time Frame: Up to 8 weeks after drug administration

Secondary Outcomes

Change in Montgomery-Asberg Depression Rating Scale (MADRS) total score(Up to 8 weeks after drug administration)
Clinical Global Impressions (CGIs) by investigator rated on CGI-improvement scale(Up to 8 weeks after drug administration)
Number of patients with adverse events(Up to 8 weeks after drug administration)
Number of patients withdrawing due to adverse event(Up to 8 weeks after drug administration)
Patients Global Impression (PGI) rated on PGI-improvement scale(Up to 8 weeks after drug administration)
Time to sustained clinical response for Painful Physical Symptoms (PPS) according BPI-SF score(Up to 8 weeks after drug administration)
Change of patient symptoms rated on Symptom Checklist 90 Revised (SCL-90-R) scale(Up to 8 weeks after drug administration)
Number of patients with clinical significant findings in laboratory values(Up to 8 weeks after drug administration)
Time to sustained clinical response for overall depression symptoms(Up to 8 weeks after drug administration)
Number of patients with clinical significant findings in vital signs(Up to 8 weeks after drug administration)
Number of patients with clinical significant findings in weight(Up to 8 weeks after drug administration)
Clinical Global Impressions (CGIs) by investigator rated on CGI-severity score(Up to 8 weeks after drug administration)