Depressive Disorder, MajorPhase 4NCT02229825
Study to Assess Clinical Response of Duloxetine in Patients Hospitalized for Severe Depression
A Phase 4 study testing Duloxetine in people with Depressive Disorder, Major, run by Boehringer Ingelheim.
Trial summary
Study to assess efficacy of Duloxetine 120 mg and Duloxetine 60 mg in patients hospitalized for severe depression after 4 weeks of treatment. To evaluate the rescue option in non-responding patients. Safety of Duloxetine will also be assessed. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 339 participants
- Where
- No sites listed yet
- Study dates
- 9 Feb 2007to 26 Aug 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 patients of 18 years of age at the screening visit or older
- Meet criteria for severe Major Depressive Disorder (MDD)
- Montgomery-Asberg-depression rating scale (MADRS) total score ≥ 30 and the 6-item Hamilton Depression scale (HAMD-6) score ≥12 at both screening (V1) visit and baseline (V2) visits
- Clinical Global Impression of Severity (CGI-Severity) score ≥4 at both screening visit and baseline visit.
- Requirement of hospitalization (not for social or other non-medical reasons) at screening visit and at least up to Visit 4
- Patient willing and able to comply with the requirement for hospitalization and with all scheduled visits, tests and procedures required by the protocol
- Have a level of understanding sufficient to provide informed consent and to communicate with the investigators and site personnel. Informed consent document must be signed at screening visit, in accordance with Good Clinical Practice (GCP) and local regulatory requirements, prior to any study procedure
Who cannot join
- More than two previous episodes of major depression that did not respond to adequate doses and duration (minimum of 6 weeks) of two different antidepressant therapies
- Lack of response to at least two antidepressant therapies given at adequate doses for at least 6 weeks for the current depressive episode
- Concurrent presence of symptoms fulfilling criteria for any Axis I disorder other than anxiety disorders (with exception of the Obsessive-Compulsive Disorder (OCD)) or Major Depressive Disorder, in the investigator's judgment
- Any previous diagnosis of a bipolar disorder, schizophrenia or OCD
- Depression with catatonic features, depression with post-partum onset, or organic mental disorders
- The presence of an Axis II disorder
Show all 27Show fewer
- MDD with psychotic features requiring neuroleptic treatment and/or interfering with patient's ability to provide informed consent, at investigator's discretion
- History of substance abuse or dependence within the past year, excluding nicotine and caffeine, but including alcohol or benzodiazepines
- Positive urine screen for drug abuse (cannabinoids, cocaine, opiates including methadone, or amphetamines) at screening
- Epilepsy or a history of seizure disorder or of a treatment with anticonvulsant medication for epilepsy or seizures
- Patients with acute liver injury (such as hepatitis) or severe cirrhosis (such as Child-Pugh Class C)
- Known diagnosis of congenital galactosaemia, glucose or galactose malabsorption syndrome, or lactose deficiency
- Patient with a known diagnosis of raised intraocular pressure, or at known risk of acute narrow-angle glaucoma
- Serious medical illness or clinically significant laboratory abnormalities that, in the judgment of the investigator, are likely to require intervention/exclusion of study medication during the course of the study: cardiovascular (e.g. uncontrolled hypertension, abnormal initial ECG findings according to investigator judgement), respiratory, haematological, hepatic or gastrointestinal
- End stage renal disease (estimated creatinine clearance ≤30 mL/min) and undergoing dialysis
- Abnormal thyroid-stimulating hormone (TSH) concentrations, based on the performing laboratory's reference ranges. Patients must be clinically and chemically euthyroid at the time of randomization. Patients may be taking thyroid replacement therapy provided their dose is stable and their compliance is good for at least three months before the screening visit
- Pregnancy (to be excluded by urine pregnancy test at screening visit) or breast-feeding
- Sexually active woman of childbearing potential (i.e. not 6 months post-menopausal, or not surgically sterilized) not using a medically approved method of birth control (i.e. oral contraceptives, intrauterine device, or double-barrier) for at least one month prior to the screening visit and throughout the study
- Participation in another clinical trial within 30 days prior to screening visit
- Current treatment with Duloxetine for any indication and previous treatment with Duloxetine for psychiatric indications
- Known hypersensitivity to Duloxetine or any of the inactive ingredients
- History of oversensitivity to psychotropic drugs, in the investigator's judgment
- Electro-convulsive Therapy (ECT) or Transcranial Magnetic Stimulation (TMS) within one year prior to screening visit and during the study
- Initiation or discontinuation of depression-oriented psychotherapeutic treatment (e.g. behaviour 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
- Treatment with a Monoamine Oxidase Inhibitor (MAOI) within 14 days prior to baseline visit or the potential need to use an MAOI during the study or within 5 days after discontinuation of duloxetine
- Treatment with Fluoxetine within 30 days prior to baseline visit
- Treatment with any excluded medication listed in the protocol
About this study
Official title: An Eight-week, Randomized, Double-blind, Two Parallel Groups, Study to Assess Clinical Response of Duloxetine 60 mg and 120 mg Per Day in Patients Hospitalized for Severe Depression
Study to assess efficacy of Duloxetine 120 mg and Duloxetine 60 mg in patients hospitalized for severe depression after 4 weeks of treatment. To evaluate the rescue option in non-responding patients. Safety of Duloxetine will also be assessed.
- 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
Capsule
PlaceboDrug
Capsule
| Study group | Role | What they receive |
|---|---|---|
| Duloxetine 60 mg | Experimental | Duloxetine 60 mg Receives: Drug: Duloxetine; Drug: Placebo |
| Duloxetine 120 mg | Experimental | Duloxetine 120 mg Receives: Drug: Duloxetine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 4
The MADRS total score is used to measure the severity of depression. It is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) scored from 0 to 6 each. The total score is calculated as the sum over the 10 items, ranging from 0 to 60. A lower score indicates a better outcome.
Missing items (≤2 items) were replaced by the mean score of the participant's treatment group per time point. Otherwise, the MADRS total score was set to missing.
Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine).
Measured: At baseline and at Week 4.
Secondary outcomes (25)
Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 1, 2, 3 and Week 4
HAMD-6 is a 6-item rating instrument that assesses items thought to represent 'core' symptoms of depression. It was derived from standard 17-item Hamilton Depression Scale (HAMD-17) with assessment being restricted to items 1, 2, 7, 8, 10 and 13. The HAMD-6 score is calculated as the sum over the 6 items, ranging from 0 to 22, with a lower score indicating a better patient status.
Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine).
Measured: At baseline and at Week 1, 2, 3 and Week 4.
Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 6 and Week 8 - by Post-week 4 Treatment Groups
HAMD-6 is a 6-item rating instrument that assesses items thought to represent 'core' symptoms of depression. It was derived from standard 17-item Hamilton Depression Scale (HAMD-17) with assessment being restricted to items 1, 2, 7, 8, 10 and 13. The HAMD-6 score is calculated as the sum over the 6 items, ranging from 0 to 22, with a lower score indicating a better patient status.
Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups.
Measured: At baseline and at Week 6 and Week 8.
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 1, 2 and Week 3
The MADRS total score is used to measure the severity of depression. It is based total score is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) ranging from 0 to 6 each. The total score is calculated as the sum over the 10 items, ranging from 0 to 60. A lower score indicates a better outcome.
Missing items (≤2 items) were replaced by the mean score of the participant's treatment group per time point. Otherwise, the MADRS total score was set to missing.
Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine).
Measured: At baseline and at Week 1, 2 and Week 3.
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 6 and Week 8 - by Post-week 4 Treatment Groups
The MADRS total score is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) ranging from 0 to 6 each. The total score is calculated as the sum over the 10 items, ranging from 0 to 60. A lower score indicates a better outcome.
Missing items (≤2 items) were replaced by the mean score of the participant's treatment group per time point. Otherwise, the MADRS total score was set to missing.
Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups.
Measured: At baseline and at Week 6 and Week 8.
Percentage of Responders at Week 1, 2, 3 and Week 4 According to Montgomery-Asberg Depression Rating Scale (MADRS) Scale
Percentage of patient 'responders', i.e. patients with at least a 50% improvement in MADRS scores from baseline.
The MADRS total score is used to measure the severity of depression. It is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) ranging from 0 to 6 each. The total score is calculated as the sum over the 10 items, ranging from 0 to 60. A lower score indicates a better outcome.
Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine).
Measured: At week 1, 2, 3 and week 4.
Percentage of Responders at Week 6 and Week 8 According to Montgomery-Asberg Depression Rating Scale (MADRS) Scale - by Post-week 4 Treatment Groups
Percentage of patient 'responders', i.e. patients with at least a 50% improvement in MADRS scores from baseline.
The MADRS total score is used to measure the severity of depression. It is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) ranging from 0 to 6 each. The total score is calculated as the sum over the 10 items, ranging from 0 to 60. A lower score indicates a better outcome.
Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups.
Measured: At week 6 and week 8.
Percentage of Responders at Week 1, 2, 3 and Week 4 According to Hamilton Depression 6-item Scale (HAMD-6)
Percentage of patient 'responders', i.e. patients with at least a 50% improvement in HAMD-6 scores from baseline.
HAMD-6 is a 6-item rating instrument that assesses items thought to represent 'core' symptoms of depression. It was derived from standard 17-item Hamilton Depression Scale (HAMD-17) with assessment being restricted to items 1, 2, 7, 8, 10 and 13. The HAMD-6 score is calculated as the sum over the 6 items, ranging from 0 to 22, with a lower score indicating a better patient status.
Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine).
Measured: At week 1, 2, 3 and week 4.
Percentage of Responders at Week 6 and Week 8 According to Hamilton Depression 6-item Scale (HAMD-6) - by Post-week 4 Treatment Group
Percentage of patient 'responders', i.e. patients with at least a 50% improvement in HAMD-6 scores from baseline.
HAMD-6 is a 6-item rating instrument that assesses items thought to represent 'core' symptoms of depression. It was derived from standard 17-item Hamilton Depression Scale (HAMD-17) with assessment being restricted to items 1, 2, 7, 8, 10 and 13. The HAMD-6 score is calculated as the sum over the 6 items, ranging from 0 to 22, with a lower score indicating a better patient status.
Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups.
Measured: At week 6 and week 8.
Percentage of Patients Reaching Remission at Week 8
Remission is defined as a total Montgomery-Asberg Depression Rating Scale (MADRS) score of ≤ 12 at week 8.
The MADRS total score is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) ranging from 0 to 6 each and a total MADRS score ranging from 0 to 60.
Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups.
Measured: At week 8.
Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4
Clinical Global Impression (CGI) scales were developed as an independent, simple way for clinicians to make overall evaluations of a patient's disease status. The CGI-SI assess the severity of illness, with the following question: "Considering your total clinical experience with the particular population, how mentally ill is the patient at this time?". The CGI-SI ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). A higher score indicates a worse patient status.
Reported is the number of patients per score by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine).
At week 4 treatment groups were compared using the Cochran Mantel-Haenszel test with stratification by centre.
Measured: At baseline and at week 1, 2, 3 and week 4.
Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups
The Clinical Global Impressions scales of Severity of Illness (CGI-SI) were developed as an independent, simple way for clinicians to make overall evaluations of a patient's disease status. The CGI-SI assess the severity of illness, with the following question: "Considering your total clinical experience with the particular population, how mentally ill is the patient at this time?".
The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). A higher score indicates a worse patient status.
Number of patients per score is reported. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups.
At week 8, within-group comparison versus week 4 was performed for each post-week 4 treatment group using Mc Nemar test.
Measured: At week 6 and week 8.
Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4
The Clinical Global Impression of Improvement (CGI-I) scale was developed as an independent, simple way for clinicians to make overall evaluations of a patients disease status. The CGI-I rates the total improvement with the following question:
"Compared to the patients condition at admission, how much has he or she changed?". The scale ranges from 1 (very much improved) to 7 (very much worse). A higher score indicates a worse patient status.
Number of patients per score is reported. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine).
At week 4 treatment groups were compared using the Cochran Mantel-Haenszel test with stratification by centre.
Measured: At week 1, 2, 3 and week 4.
Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups
Clinical Global Impression (CGI) scale was developed as an independent, simple way for clinicians to make overall evaluations of a patients disease status. The CGI-I rates the total improvement with the following question:
"Compared to the patients condition as admission, how much has he or she changed?". The CGI-I score ranges from 1 (very much improved) to 7 (very much worse). A higher score indicates a worse patient outcome.
Number of patients per score is reported. Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups.
Measured: At week 6 and week 8.
Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4
Patient Global Impression of Improvement scale is a patient-rated instrument that measures the improvement of the patient's symptoms, ranging from 1 (very much better) to 7 (much worse). A higher score indicates a worse outcome.
Number of patients per score is reported. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine).
At week 4 treatment groups were compared using the Cochran Mantel-Haenszel test with stratification by centre.
Measured: At week 1, 2, 3 and week 4.
Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups
Patient Global Impression of Improvement scale is a patient-rated instrument that measures the improvement of the patient's symptoms, ranging from 1 (very much better) to 7 (much worse). A higher score indicates a worse outcome.
Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups.
Measured: At week 6 and week 8.
Change in Hamilton Scale of Anxiety (HAMA) Score From Baseline to Week 4
HAMA scale consists of 14 items to measure the severity of anxiety symptoms. Each item ranges from 0 (not present) to 4 (very severe). The total score is calculated as the sum over all items, ranging from 0 to 56, with a higher score implying a worse outcome. Change from baseline to week 4 is reported. Reduction in the score over time is interpreted as improvement in the patient´s status.
Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine).
Measured: At baseline and at week 4.
Change in Hamilton Scale of Anxiety (HAMA) Score From Baseline to Week 8 - by Post-week 4 Treatment Groups
HAMA scale consists of 14 items to measure the severity of anxiety symptoms. Each item ranges from 0 (not present) to 4 (very severe). The total score is calculated as the sum over all items, ranging from 0 to 56, with a higher score implying a worse outcome. Change from baseline to week 8 is reported. Reduction in the score over time is interpreted as improvement in the patient´s status.
Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups.
Measured: At baseline and at week 8.
Reason for Living (RFL) Questionaire at Baseline
The Reason for Living (RFL) questionnaire is a self-report instrument, to evaluate a variety of expectations and adaptive beliefs for living, if suicide is considered.
The RFL is thought to assess 6 domains of reasons for living: 1) survival and coping beliefs, 2) responsibility to family, 3) child related concerns, 4) fear of suicide, 5) fear of social disapproval, and 6) moral objections.
The RFL uses a 6-point rating scale, with the total score ranging from 1 "not at all important" and to 6 "extremely important". A higher score indicates more reasons to live (i.e. better outcome).
Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine).
Measured: At baseline.
Change From Baseline to Week 8 in Reason for Living (RFL) Questionnaire - by Post-week 4 Treatment Groups
The Reason for Living (RFL) questionnaire is a self-report instrument, to evaluate a variety of expectations and adaptive beliefs for living, if suicide is considered.
The RFL is thought to assess 6 domains of reasons for living: 1) survival and coping beliefs, 2) responsibility to family, 3) child related concerns, 4) fear of suicide, 5) fear of social disapproval, and 6) moral objections.
The RFL uses a 6-point rating scale, with the total score ranging from 1 "not at all important" and to 6 "extremely important". A higher score indicates more reasons to live (i.e. better outcome).
Results are reported by 'post-week 4 treatment groups' (treatment regimen (60 vs. 120 mg duloxetine) and responder/non-responder status). Patients were assigned their responder status at Visit 6 and the data were retrospectively divided into these groups.
Measured: At baseline and at week 8.
Number of Patients With Intake of Concomitant Medication for Anxiety and Sleep
Number of patients with concomitant medication for anxiety and sleep taken at different timepoints.
V1: Screening V2: Baseline V3: Week 1 V4: Week2 V5: Week 3 V6: Week 4 V7: Week 6 V8: Week 8.
Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine).
Measured: 1 week prior to baseline and at baseline, week 1, 2, 3, 4, 5, 6, 7, 8 and week 10.
Number of Patients With Treatment Emergent Adverse Event
Number of patients with any adverse event occuring during on-treatment phase.
Results are reported for treatment regimen (60 mg duloxetine vs. 120 mg duloxetine).
Measured: From start of treatment until 3 days after end of treatment, up to 120 days.
Change From Baseline in Blood Pressure to Week 4 and Week 8
Change from baseline in systolic and diastolic blood pressure (BP) to week 4 and week 8.
Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine).
Measured: At baseline, at week 4 and week 8.
Change From Baseline in Weight to Week 4 and Week 8
Change from baseline in weight to week 4 and week 8.
Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine).
Measured: At baseline, at week 4 and week 8.
Number of Patients With Potentially Clinically Significant Laboratory Findings
Number of patients with potentially clinically significant abnormalities. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine).
Measured: Up to week 8.
Number of Patients Withdrawn Due to Adverse Events
Number of patients withdrawn due to adverse events.
Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine).
Measured: From start of treatment until 3 days after end of treatment, up to 120 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2014 (estimated)
- Study start9 Feb 2007
- Primary completion26 Aug 2008
- Study completion26 Aug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 339 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02229825
- Sponsor's protocol ID
- 1208.24
- Status last verified
- Oct 2023
- First submitted
- 28 Aug 2014
- Last updated
- 23 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Eight-week, Randomized, Double-blind, Two Parallel Groups, Study to Assess Clinical Response of Duloxetine 60 mg and 120 mg Per Day in Patients Hospitalized for Severe Depression
- ClinicalTrials.gov ID
- NCT02229825
- Acronym / sponsor ID
- 1208.24
- Conditions
- Depressive Disorder, Major
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 9 Feb 2007 (actual)
- Primary completion
- 26 Aug 2008 (actual)
- Study completion
- 26 Aug 2008 (actual)
- First posted
- 1 Sep 2014 (estimated)
- Results
- Posted 23 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to assess efficacy of Duloxetine 120 mg and Duloxetine 60 mg in patients hospitalized for severe depression after 4 weeks of treatment. To evaluate the rescue option in non-responding patients. Safety of Duloxetine will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duloxetine 60 mg | Experimental | Drug: Duloxetine, Drug: PlaceboDuloxetine 60 mg |
| Duloxetine 120 mg | Experimental | Drug: Duloxetine, Drug: PlaceboDuloxetine 120 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patients of 18 years of age at the screening visit or older
- Meet criteria for severe Major Depressive Disorder (MDD)
- Montgomery-Asberg-depression rating scale (MADRS) total score ≥ 30 and the 6-item Hamilton Depression scale (HAMD-6) score ≥12 at both screening (V1) visit and baseline (V2) visits
- Clinical Global Impression of Severity (CGI-Severity) score ≥4 at both screening visit and baseline visit.
- Requirement of hospitalization (not for social or other non-medical reasons) at screening visit and at least up to Visit 4
Key exclusion criteria (27 listed)
- More than two previous episodes of major depression that did not respond to adequate doses and duration (minimum of 6 weeks) of two different antidepressant therapies
- Lack of response to at least two antidepressant therapies given at adequate doses for at least 6 weeks for the current depressive episode
- Concurrent presence of symptoms fulfilling criteria for any Axis I disorder other than anxiety disorders (with exception of the Obsessive-Compulsive Disorder (OCD)) or Major Depressive Disorder, in the investigator's judgment
- Any previous diagnosis of a bipolar disorder, schizophrenia or OCD
- Depression with catatonic features, depression with post-partum onset, or organic mental disorders
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 |
|---|---|---|
| DuloxetineCapsule | Drug | Duloxetine 120 mg, Duloxetine 60 mg |
| PlaceboCapsule | Drug | Duloxetine 120 mg, Duloxetine 60 mg |
Primary outcome
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 4
Time frame: At baseline and at Week 4.
The MADRS total score is used to measure the severity of depression. It is based on 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts) scored from 0 to 6 each. The total score is calculated as the sum over the 10 items, ranging from 0 to 60. A lower score indicates a better outcome. Missing items (≤2 items) were replaced by the mean score of the participant's treatment group per time point. Otherwise, the MADRS total score was set to missing. Results are reported by treatment regimen (60 mg duloxetine vs. 120 mg duloxetine).
25 secondary outcomes
Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 1, 2, 3 and Week 4
Time frame: At baseline and at Week 1, 2, 3 and Week 4.
Change in Hamilton Depression 6-item Scale (HAMD-6) Total Score From Baseline to Week 6 and Week 8 - by Post-week 4 Treatment Groups
Time frame: At baseline and at Week 6 and Week 8.
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 1, 2 and Week 3
Time frame: At baseline and at Week 1, 2 and Week 3.
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 6 and Week 8 - by Post-week 4 Treatment Groups
Time frame: At baseline and at Week 6 and Week 8.
Percentage of Responders at Week 1, 2, 3 and Week 4 According to Montgomery-Asberg Depression Rating Scale (MADRS) Scale
Time frame: At week 1, 2, 3 and week 4.
Percentage of Responders at Week 6 and Week 8 According to Montgomery-Asberg Depression Rating Scale (MADRS) Scale - by Post-week 4 Treatment Groups
Time frame: At week 6 and week 8.
Percentage of Responders at Week 1, 2, 3 and Week 4 According to Hamilton Depression 6-item Scale (HAMD-6)
Time frame: At week 1, 2, 3 and week 4.
Percentage of Responders at Week 6 and Week 8 According to Hamilton Depression 6-item Scale (HAMD-6) - by Post-week 4 Treatment Group
Time frame: At week 6 and week 8.
Percentage of Patients Reaching Remission at Week 8
Time frame: At week 8.
Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Baseline, Week 1, 2, 3 and Week 4
Time frame: At baseline and at week 1, 2, 3 and week 4.
Clinical Global Impressions Scales of Severity of Illness (CGI-SI): Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups
Time frame: At week 6 and week 8.
Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 1, 2, 3 and Week 4
Time frame: At week 1, 2, 3 and week 4.
Clinical Global Impression of Improvement (CGI-I) Scale: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups
Time frame: At week 6 and week 8.
Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 1, 2, 3 and Week 4
Time frame: At week 1, 2, 3 and week 4.
Patient Global Impressions of Improvement (PGI-I) Score: Number of Patients Per Score at Week 6 and Week 8 - by Post-week 4 Treatment Groups
Time frame: At week 6 and week 8.
Change in Hamilton Scale of Anxiety (HAMA) Score From Baseline to Week 4
Time frame: At baseline and at week 4.
Change in Hamilton Scale of Anxiety (HAMA) Score From Baseline to Week 8 - by Post-week 4 Treatment Groups
Time frame: At baseline and at week 8.
Reason for Living (RFL) Questionaire at Baseline
Time frame: At baseline.
Change From Baseline to Week 8 in Reason for Living (RFL) Questionnaire - by Post-week 4 Treatment Groups
Time frame: At baseline and at week 8.
Number of Patients With Intake of Concomitant Medication for Anxiety and Sleep
Time frame: 1 week prior to baseline and at baseline, week 1, 2, 3, 4, 5, 6, 7, 8 and week 10.
Number of Patients With Treatment Emergent Adverse Event
Time frame: From start of treatment until 3 days after end of treatment, up to 120 days.
Change From Baseline in Blood Pressure to Week 4 and Week 8
Time frame: At baseline, at week 4 and week 8.
Change From Baseline in Weight to Week 4 and Week 8
Time frame: At baseline, at week 4 and week 8.
Number of Patients With Potentially Clinically Significant Laboratory Findings
Time frame: Up to week 8.
Number of Patients Withdrawn Due to Adverse Events
Time frame: From start of treatment until 3 days after end of treatment, up to 120 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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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 4 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 7 inclusion and 27 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 23 Oct 2023. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline to Week 4 (time frame: At baseline and at Week 4.). 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 23 Oct 2023.