Study to Evaluate the Efficacy of Duloxetine in Outpatients With Major Depressive Disorder and Pain

NCT02232555 | Completed Phase 3

• 1 other identifier: 1208.10
• Study Type: interventional
• Target: 327
• Locations: 0 countries
• Sites: N/A

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

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

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

  Up to 8 weeks after drug administration

Secondary Outcomes (12)

• Change in Montgomery-Asberg Depression Rating Scale (MADRS) total score

  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

• Patients Global Impression (PGI) rated on PGI-improvement scale

  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

Study Arms (2)

Duloxetine

EXPERIMENTAL

Drug: Duloxetine

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Duloxetine DRUG

Duloxetine

Placebo DRUG

Placebo

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 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

You may not qualify if:

• 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)
• Patients requiring continuous treatment with analgesics (\> step 2 WHO definition) because of chronic pain (\> 6 months)
• Patients with organic pain syndromes
• Epilepsy or history of seizure disorder or of a treatment with anticonvulsant medication for epilepsy or seizures
• Patients with a known diagnosis of raised intraocular pressure or at risk of acute narrow-angle glaucoma
• Known diagnosis of congenital galactosaemia, glucose or galactose malabsorption syndrome, or lactose deficiency
• Patients with severely impaired renal function, defined by a creatinine clearance \< 30 mL/min (creatinine clearance was calculated by the central laboratory from the screening safety laboratory test
• Acute liver injury (such as hepatitis) or severe (Child-Pugh Class C) cirrhosis
• Abnormal initial ECG findings according to investigator's judgement

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2014
• First Posted: September 5, 2014
• Study Start: May 1, 2005
• Primary Completion: May 1, 2006
• Last Updated: September 5, 2014

Record last verified: 2014-08