Status:
COMPLETED
Study to Evaluate the Efficacy of Duloxetine in Outpatients With Major Depressive Disorder and Pain
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Depressive Disorder, Major
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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) 2...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
327 Patients enrolled
Trial Details
Trial ID
NCT02232555
Start Date
May 1 2005
Last Update
September 5 2014
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