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Study to Assess Clinical Response of Duloxetine in Patients Hospitalized for Severe Depression

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ClinicalTrials.gov Identifier: NCT02229825
Recruitment Status : Completed
First Posted : September 1, 2014
Last Update Posted : September 1, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief 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.

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: Duloxetine high Drug: Duloxetine low Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 339 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : February 2007
Actual Primary Completion Date : August 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Duloxetine low Drug: Duloxetine low
Experimental: Duloxetine high Drug: Duloxetine high



Primary Outcome Measures :
  1. Change in the Montgomery-Asberg Depression Rating Scale (MADRS) total score [ Time Frame: baseline, week 4 ]

Secondary Outcome Measures :
  1. Change in the Hamilton Depression 6-item scale (HAMD-6) total score [ Time Frame: baseline, up to 8 weeks ]
  2. Change in the MADRS total score [ Time Frame: baseline, up to 8 weeks ]
  3. Changes in the MADRS and HAMD-6 total scores following dose up-titration [ Time Frame: 4 weeks, up to 8 weeks ]
    in patients that did not achieve minimum of 50 % response at primary endpoint

  4. Number of responders [ Time Frame: up to 8 weeks ]
    defined as ≥ 50 % reduction of the MADRS and ≥ 50 % reduction of the HAMD-6 score

  5. Number of patients reaching remission [ Time Frame: week 8 ]
    defined as a total MADRS score of ≤ 12

  6. Reduction of Clinical Global Impressions scales of Severity of Illness (CGI-SI) [ Time Frame: up to 8 weeks ]
  7. Change in clinical Global Impressions of Improvement (CGI-I) score [ Time Frame: up to 8 weeks ]
  8. Change in patient Global Impressions of Improvement (PGI-I) score [ Time Frame: up to 8 weeks ]
  9. Change in Hamilton Scale of Anxiety (HAMA) score [ Time Frame: up to 8 weeks ]
  10. Reason for Living (RFL) questionnaire score [ Time Frame: up to 8 weeks ]
  11. Utilization of allowed hypnotic and anxiolytic comedication [ Time Frame: up to 8 weeks ]
  12. Number of patients with treatment-emergent adverse events [ Time Frame: up to 10 weeks ]
  13. Number of patients with clinically significant changes in vital signs [ Time Frame: up to 10 weeks ]
    incl. weight

  14. Number of patients with clinically significant changes in laboratory assessments [ Time Frame: up to 8 weeks ]
  15. Number of withdrawals due to adverse events [ Time Frame: up to 10 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients of 18 years of age at the screening visit or older
  2. Meet criteria for severe Major Depressive Disorder (MDD)
  3. 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
  4. Clinical Global Impression of Severity (CGI-Severity) score ≥4 at both screening visit and baseline visit.
  5. Requirement of hospitalization (not for social or other non-medical reasons) at screening visit and at least up to Visit 4
  6. Patient willing and able to comply with the requirement for hospitalization and with all scheduled visits, tests and procedures required by the protocol
  7. 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

Exclusion Criteria:

  1. 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
  2. Lack of response to at least two antidepressant therapies given at adequate doses for at least 6 weeks for the current depressive episode
  3. 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
  4. Any previous diagnosis of a bipolar disorder, schizophrenia or OCD
  5. Depression with catatonic features, depression with post-partum onset, or organic mental disorders
  6. The presence of an Axis II disorder
  7. MDD with psychotic features requiring neuroleptic treatment and/or interfering with patient's ability to provide informed consent, at investigator's discretion
  8. History of substance abuse or dependence within the past year, excluding nicotine and caffeine, but including alcohol or benzodiazepines
  9. Positive urine screen for drug abuse (cannabinoids, cocaine, opiates including methadone, or amphetamines) at screening
  10. Epilepsy or a history of seizure disorder or of a treatment with anticonvulsant medication for epilepsy or seizures
  11. Patients with acute liver injury (such as hepatitis) or severe cirrhosis (such as Child-Pugh Class C)
  12. Known diagnosis of congenital galactosaemia, glucose or galactose malabsorption syndrome, or lactose deficiency
  13. Patient with a known diagnosis of raised intraocular pressure, or at known risk of acute narrow-angle glaucoma
  14. 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
  15. End stage renal disease (estimated creatinine clearance ≤30 mL/min) and undergoing dialysis
  16. 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
  17. Pregnancy (to be excluded by urine pregnancy test at screening visit) or breast-feeding
  18. 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
  19. Participation in another clinical trial within 30 days prior to screening visit
  20. Current treatment with Duloxetine for any indication and previous treatment with Duloxetine for psychiatric indications
  21. Known hypersensitivity to Duloxetine or any of the inactive ingredients
  22. History of oversensitivity to psychotropic drugs, in the investigator's judgment
  23. Electro-convulsive Therapy (ECT) or Transcranial Magnetic Stimulation (TMS) within one year prior to screening visit and during the study
  24. 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
  25. 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
  26. Treatment with Fluoxetine within 30 days prior to baseline visit
  27. Treatment with any excluded medication listed in the protocol

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02229825     History of Changes
Other Study ID Numbers: 1208.24
First Posted: September 1, 2014    Key Record Dates
Last Update Posted: September 1, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents