Depressive Disorder, MajorPhase 3NCT02232555
Study to Evaluate the Efficacy of Duloxetine in Outpatients With Major Depressive Disorder and Pain
A Phase 3 study testing Duloxetine in people with Depressive Disorder, Major, run by Boehringer Ingelheim.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- Duloxetine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 327 participants
- Where
- No sites listed yet
- Study dates
- May 2005to May 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 30Show fewer
- 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
About this study
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)
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
- Being tested
- Duloxetine, Placebo
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Duloxetine | Experimental | Not described Receives: Drug: Duloxetine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of 24-hour average pain rated on Brief Pain Inventory-Short Form (BPI-SF) score
Measured: Up to 8 weeks after drug administration
Secondary outcomes (12)
Change in Montgomery-Asberg Depression Rating Scale (MADRS) total score
Measured: Up to 8 weeks after drug administration
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
Measured: Up to 8 weeks after drug administration
Change of patient symptoms rated on Symptom Checklist 90 Revised (SCL-90-R) scale
Measured: Up to 8 weeks after drug administration
Patients Global Impression (PGI) rated on PGI-improvement scale
Measured: Up to 8 weeks after drug administration
Clinical Global Impressions (CGIs) by investigator rated on CGI-severity score
Measured: Up to 8 weeks after drug administration
Clinical Global Impressions (CGIs) by investigator rated on CGI-improvement scale
Measured: Up to 8 weeks after drug administration
Time to sustained clinical response for overall depression symptoms
as defined by a 50% reduction from baseline in MADRS score
Measured: Up to 8 weeks after drug administration
Number of patients with adverse events
Measured: Up to 8 weeks after drug administration
Number of patients withdrawing due to adverse event
Measured: Up to 8 weeks after drug administration
Number of patients with clinical significant findings in vital signs
blood pressure, pulse rate
Measured: Up to 8 weeks after drug administration
Number of patients with clinical significant findings in weight
Measured: Up to 8 weeks after drug administration
Number of patients with clinical significant findings in laboratory values
Measured: Up to 8 weeks after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2014 (estimated)
- Study startMay 2005
- Primary completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 327 participants
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02232555
- Sponsor's protocol ID
- 1208.10
- Status last verified
- Aug 2014
- First submitted
- 4 Sep 2014
- Last updated
- 5 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02232555
- Acronym / sponsor ID
- 1208.10
- Conditions
- Depressive Disorder, Major
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 327 participants
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- May 2006 (actual)
- First posted
- 5 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duloxetine | Experimental | Drug: Duloxetine |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (30 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Duloxetine | Drug | Duloxetine |
| Placebo | Drug | Placebo |
Primary outcome
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
12 secondary outcomes
Change in Montgomery-Asberg Depression Rating Scale (MADRS) total score
Time frame: Up to 8 weeks after drug administration
Time to sustained clinical response for Painful Physical Symptoms (PPS) according BPI-SF score
Time frame: Up to 8 weeks after drug administration
Change of patient symptoms rated on Symptom Checklist 90 Revised (SCL-90-R) scale
Time frame: Up to 8 weeks after drug administration
Patients Global Impression (PGI) rated on PGI-improvement scale
Time frame: Up to 8 weeks after drug administration
Clinical Global Impressions (CGIs) by investigator rated on CGI-severity score
Time frame: Up to 8 weeks after drug administration
Clinical Global Impressions (CGIs) by investigator rated on CGI-improvement scale
Time frame: Up to 8 weeks after drug administration
Time to sustained clinical response for overall depression symptoms
Time frame: Up to 8 weeks after drug administration
Number of patients with adverse events
Time frame: Up to 8 weeks after drug administration
Number of patients withdrawing due to adverse event
Time frame: Up to 8 weeks after drug administration
Number of patients with clinical significant findings in vital signs
Time frame: Up to 8 weeks after drug administration
Number of patients with clinical significant findings in weight
Time frame: Up to 8 weeks after drug administration
Number of patients with clinical significant findings in laboratory values
Time frame: Up to 8 weeks after drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Duloxetine in people with Depressive Disorder, Major, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2014.