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Trial record 1 of 1 for:    NCT00422162
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A Study Evaluating Duloxetine in Patients Hospitalized for Severe Depression

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ClinicalTrials.gov Identifier: NCT00422162
Recruitment Status : Completed
First Posted : January 15, 2007
Results First Posted : October 2, 2009
Last Update Posted : July 26, 2011
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by:
Eli Lilly and Company

Study Description
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Brief Summary:
An eight-week, randomized, double blind, two parallel groups, study to assess clinical response of duloxetine 60 milligrams (mg) and 120 mg per day in patients hospitalized for severe depression.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Duloxetine hydrochloride Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 339 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 Per Day in Patients Hospitalized for Severe Depression
Study Start Date : February 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Duloxetine Hydrochloride (60 mg)

Up to Week 4: 60 milligrams (mg) every morning and placebo every evening, by mouth (PO).

Week 4 to Week 8: Responders continued on same dose as before; Nonresponders received 60 mg every morning and 60 mg every evening added to the placebo

 Drug: Duloxetine hydrochloride
60 mg once or twice a day, by mouth
Other Names:
  • LY248686
  • Cymbalta

Drug: Placebo
placebo capsule by mouth
Experimental: Duloxetine Hydrochloride (120 mg)

Up to Week 4: 60 mg every morning and 60 mg every evening, PO.

Week 4 to Week 8: Responders continued on same dose as before; Nonresponders continued as before with a placebo capsule added to the evening dose

 Drug: Duloxetine hydrochloride
60 mg once or twice a day, by mouth
Other Names:
  • LY248686
  • Cymbalta

Drug: Placebo
placebo capsule by mouth


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline to 4 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: Baseline to Week 4 ]
    Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).


Secondary Outcome Measures :
  1. Change in 6-Item Hamilton Depression Scale (HAMD-6) Total Scores From Baseline [ Time Frame: Baseline to Weeks 1, 2, 3, 4, 6, 8 ]
    The HAMD-6 (Items 1,2,7,8,10,13 from the 17-item HAMD) evaluates "core" symptoms of Major Depressive Disorder (MDD). Total scores range from 0 (normal) to 22 (severe).

  2. Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From Baseline [ Time Frame: Baseline to Weeks 1, 2, 3, 4, 6, 8 ]
    Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).

  3. Evaluation of Rescue Options Based on Changes in the Montgomery-Asberg Depression Rating Scale (MADRS) and the 6-Item Hamilton Depression Scale (HAMD-6) [ Time Frame: 4 to 8 weeks ]
    Changes in Montgomery-Åsberg Depression Rating Scale (MADRS) and 6-Item Hamilton Depression Scale (HAMD-6) total scores were evaluated following dose up-titration in those patients who did not achieve the minimum 50% response for primary endpoint. MADRS is a rating scale for severity of depressive mood symptoms. Total scores range from 0 (low severity of symptoms) to 60 (high severity of symptoms). The HAMD-6, derived by the sum of HAMD-17 items 1, 2, 7, 8, 10 and 13, evaluates "core" symptoms of Major Depressive Disorder (MDD). Total subscale scores range from 0 (normal) to 22 (severe).

  4. Clinical Global Impression of Severity (CGI-S) Scores at Each Visit [ Time Frame: Baseline, Weeks 1, 2, 3, 4, 6, 8 ]
    Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).

  5. Clinical Global Impression of Improvement (CGI-I) at Each Visit [ Time Frame: Weeks 1, 2, 3, 4, 6, 8 ]
    Measures clinician's perception of patient improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much better) to 7 (very much worse).

  6. Patient Global Impression of Improvement (PGI-I) Score at Each Visit [ Time Frame: Weeks 1, 2, 3, 4, 6, 8 ]
    A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).

  7. Hamilton Anxiety Scale (HAMA) Score at Baseline and Weeks 4 and 8 [ Time Frame: Baseline and Weeks 4 and 8 ]
    The HAMA scale measures anxiety symptoms accompanying Major Depressive Disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56.

  8. Percentage of Responders [ Time Frame: 4 to 8 weeks ]
    Patients with reduction in MADRS score ≥50% after 4 weeks were to stay on previous dose of duloxetine. Those with reduction in MADRS <50% were to receive 120 mg for remaining 4 weeks of treatment (up-titration from 60 mg to 120 mg for those randomized to 60 mg, and addition of placebo to 120 mg dose for those randomized to 120 mg). However, 2/70 patients randomized to 60 mg and then up-titrated to 120 mg after 4 weeks had reduction in MADRS ≥50% after 4 weeks, and 3/64 patients randomized to 120 mg and then given placebo in addition after 4 weeks had reduction in MADRS ≥50% after 4 weeks.

  9. Patients Reaching Remission [ Time Frame: Week 8 ]
    Major Depressive Disorder remission was defined as a total MADRS score ≤12 at Week 8.

  10. Reason for Living (RFL) Questionnaire Mean Scores at Baseline and Week 8 [ Time Frame: Baseline and Week 8 ]
    The RFL questionnaire is an instrument that evaluates patient's reasons for not committing suicide using a 6-point rating scale, where 1 is "not at all important" and 6 is "extremely important". The questionnaire required participants to rate how important each item would be for living, if suicide was contemplated. Mean scores could range from 0 to 6.

  11. Utilization of Allowed Hypnotic and/or Anxiolytic Co-Medication [ Time Frame: over 8 weeks ]
    Number of participants using medication for anxiety and sleep disturbances.

  12. Number of Patients With Potentially Clinically Significant Laboratory Findings [ Time Frame: over 8 weeks ]
    Laboratory results that were potentially clinically significant.

  13. Discontinuations Due to Adverse Events (AE) [ Time Frame: over 8 weeks ]
    Listing of adverse events (AE) that led to treatment discontinuation (DC).

  14. Number of Participants Experiencing High Values for Vital Signs at Any Time During the Study [ Time Frame: over 8 weeks ]
    Systolic and diastolic blood pressure and pulse rate were measured after 2 minutes rest in a supine position. High values were: diastolic blood pressure ≥90 mm Hg and increase from baseline of ≥10 mm Hg; systolic blood pressure ≥140 mm Hg and increase from baseline of ≥10 mm Hg; pulse rate ≥100 beats per minute (bpm) and an increase of ≥10 bpm from baseline.

  15. Change From Baseline to Week 4 and Week 8 in Weight [ Time Frame: Baseline to Weeks 4 and 8 ]
    Change in weight = Post-baseline visit minus baseline.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

Male or female patients of ≥ 18 years of age that meet criteria for severe Major Depressive Disorder, without psychotic features (according to Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, [DSM-IV] and confirmed by Mini International Neuropsychiatric Interview [MINI]).

  • With a total score Montgomery-Asberg Depression Rating Scale (MADRS) ≥ 30 and 6-item Hamilton Depression Rating Scale (HAMD-6) ≥ 12 and Clinical Global Impression of Severity (CGI-Severity) ≥ 4 at both screening and baseline.
  • Requirement of hospitalization (not for social or other non-medical reasons) at screening visit and at least up to Visit 4.
  • Patients willing and able to comply with the requirement for hospitalization and with all scheduled visits, tests and procedures required by the protocol.
  • 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:

  • More than two previous episodes of major depression that did not respond (according to investigator's opinion) to adequate doses and duration 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 (according to DSM-IV), depression with post-partum onset, or organic mental disorders.
  • The presence of an Axis II disorder
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00422162


Locations
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France
For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician
Besancon, France
For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician
Bordeaux, France
For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician
Bully les Mines, France
For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician
Chateau-Gontier, France
For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician
Dijon, France
For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician
Dole, France
For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician
Fains Veel, France
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Jarnac, France
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La Charite sur Loire, France
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La Rochelle, France
For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician
Limoges, France
For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician
Marseille, France
For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician
Montberon, France
For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician
Montpellier, France
For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician
Nimes, France
For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician
Paris, France
For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician
Saint-Dizier, France
Italy
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Firenze, Italy
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Foggia, Italy
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Messina, Italy
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Milano, Italy
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Pisa, Italy
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Roma, Italy
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Siena, Italy
Russian Federation
For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician
Kazan, Russian Federation
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Lipetsk, Russian Federation
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Moscow, Russian Federation
For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician
Nizhny Novgorod, Russian Federation
For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician
Saratov, Russian Federation
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St. Petersburg, Russian Federation
South Africa
For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician
Bryanston, South Africa
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Cape Town, South Africa
For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician
George, South Africa
For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician
Krugersdorp, South Africa
For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559), Mon-Fri, 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST) or speak with your personal physician
Pretoria, South Africa
Sponsors and Collaborators
Eli Lilly and Company
Boehringer Ingelheim
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00422162    
Other Study ID Numbers: 10614
F1J-BI-HMES ( Other Identifier: Eli Lilly and Company )
First Posted: January 15, 2007    Key Record Dates
Results First Posted: October 2, 2009
Last Update Posted: July 26, 2011
Last Verified: July 2011
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
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