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

Depressive Disorder, Major Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02232555
• Other study ID #: 1208.10
• Status: Completed
• Phase: Phase 3
• First received: September 4, 2014
• Last updated: September 4, 2014
• Start date: May 2005

Study information

• Verified date: August 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 327
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

• 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

• Serious medical illness or clinically significant laboratory abnormalities which, in the judgement of the investigator, are likely to require medication/ intervention or hospitalization during the course of the study

• Women of childbearing potential not using a medically accepted means of contraception when engaging in sexual intercourse (e.g. intrauterine device, oral contraceptive, contraceptive patch, implant, or barrier devices)

• Women who are pregnant or breast-feeding

Pharmacological and other exclusions

• Participation in another clinical trial within 30 days prior to screening (Visit 1)

• Patients who have previously completed or withdrawn from this or any other study investigating duloxetine or have previously been treated with duloxetine

• Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to Visit 2 or potential need to use a MAOI within 5 days after discontinuation of study drug

• Treatment with fluoxetine within 28 days prior to Visit 2

• Treatment with any of excluded medications (listed in Protocol) within 7 days prior to Visit 2

• (excepted MAOI within 14 days and fluoxetine within 28 days)

• Frequent and/or severe allergic reactions with multiple medications. Known hypersensitivity to duloxetine or any of the inactive ingredients

• Electro-convulsive Therapy (ECT) or Transcranial Magnetic Stimulation (TMS) within one year prior to screening

• Initiation or discontinuation of depression-oriented psychotherapeutic treatment (e.g. behavioural therapy, psychoanalytic therapy, cognitive therapy etc.) within 6 weeks prior to screening visit or planned use of such treatment at any time during the study

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Drug:
• Duloxetine

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of 24-hour average pain rated on Brief Pain Inventory-Short Form (BPI-SF) score		Up to 8 weeks after drug administration	No
Secondary	Change in Montgomery-Asberg Depression Rating Scale (MADRS) total score		Up to 8 weeks after drug administration	No
Secondary	Time to sustained clinical response for Painful Physical Symptoms (PPS) according BPI-SF score	as defined by 30% reduction from baseline in question 5 (average pain) of the BPI-SF score	Up to 8 weeks after drug administration	No
Secondary	Change of patient symptoms rated on Symptom Checklist 90 Revised (SCL-90-R) scale		Up to 8 weeks after drug administration	No
Secondary	Patients Global Impression (PGI) rated on PGI-improvement scale		Up to 8 weeks after drug administration	No
Secondary	Clinical Global Impressions (CGIs) by investigator rated on CGI-severity score		Up to 8 weeks after drug administration	No
Secondary	Clinical Global Impressions (CGIs) by investigator rated on CGI-improvement scale		Up to 8 weeks after drug administration	No
Secondary	Time to sustained clinical response for overall depression symptoms	as defined by a 50% reduction from baseline in MADRS score	Up to 8 weeks after drug administration	No
Secondary	Number of patients with adverse events		Up to 8 weeks after drug administration	No
Secondary	Number of patients withdrawing due to adverse event		Up to 8 weeks after drug administration	No
Secondary	Number of patients with clinical significant findings in vital signs	blood pressure, pulse rate	Up to 8 weeks after drug administration	No
Secondary	Number of patients with clinical significant findings in weight		Up to 8 weeks after drug administration	No
Secondary	Number of patients with clinical significant findings in laboratory values		Up to 8 weeks after drug administration	No

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