A Study Evaluating Duloxetine in Patients Hospitalized for Severe Depression
This study has been completed.
Sponsor:
Eli Lilly and Company
Collaborator:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00422162
First received: January 11, 2007
Last updated: July 22, 2011
Last verified: July 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Major Depressive Disorder |
Drug: Duloxetine hydrochloride Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Change From Baseline to 4 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: Baseline to Week 4 ] [ Designated as safety issue: No ]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:
- Change in 6-Item Hamilton Depression Scale (HAMD-6) Total Scores From Baseline [ Time Frame: Baseline to Weeks 1, 2, 3, 4, 6, 8 ] [ Designated as safety issue: No ]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).
- Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From Baseline [ Time Frame: Baseline to Weeks 1, 2, 3, 4, 6, 8 ] [ Designated as safety issue: No ]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).
- 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 ] [ Designated as safety issue: No ]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).
- Clinical Global Impression of Severity (CGI-S) Scores at Each Visit [ Time Frame: Baseline, Weeks 1, 2, 3, 4, 6, 8 ] [ Designated as safety issue: No ]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).
- Clinical Global Impression of Improvement (CGI-I) at Each Visit [ Time Frame: Weeks 1, 2, 3, 4, 6, 8 ] [ Designated as safety issue: No ]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).
- Patient Global Impression of Improvement (PGI-I) Score at Each Visit [ Time Frame: Weeks 1, 2, 3, 4, 6, 8 ] [ Designated as safety issue: No ]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).
- Hamilton Anxiety Scale (HAMA) Score at Baseline and Weeks 4 and 8 [ Time Frame: Baseline and Weeks 4 and 8 ] [ Designated as safety issue: No ]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.
- Percentage of Responders [ Time Frame: 4 to 8 weeks ] [ Designated as safety issue: No ]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.
- Patients Reaching Remission [ Time Frame: Week 8 ] [ Designated as safety issue: No ]Major Depressive Disorder remission was defined as a total MADRS score ≤12 at Week 8.
- Reason for Living (RFL) Questionnaire Mean Scores at Baseline and Week 8 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]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.
- Utilization of Allowed Hypnotic and/or Anxiolytic Co-Medication [ Time Frame: over 8 weeks ] [ Designated as safety issue: No ]Number of participants using medication for anxiety and sleep disturbances.
- Number of Patients With Potentially Clinically Significant Laboratory Findings [ Time Frame: over 8 weeks ] [ Designated as safety issue: Yes ]Laboratory results that were potentially clinically significant.
- Discontinuations Due to Adverse Events (AE) [ Time Frame: over 8 weeks ] [ Designated as safety issue: Yes ]Listing of adverse events (AE) that led to treatment discontinuation (DC).
- Number of Participants Experiencing High Values for Vital Signs at Any Time During the Study [ Time Frame: over 8 weeks ] [ Designated as safety issue: Yes ]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.
- Change From Baseline to Week 4 and Week 8 in Weight [ Time Frame: Baseline to Weeks 4 and 8 ] [ Designated as safety issue: Yes ]Change in weight = Post-baseline visit minus baseline.
| Enrollment: | 339 |
| Study Start Date: | February 2007 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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:
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:
Drug: Placebo
placebo capsule by mouth
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00422162
Locations
| 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 | |
| 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 | |
| Jarnac, 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 | |
| La Charite sur Loire, 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 | |
| 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 | |
| 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 | |
| Firenze, Italy | |
| 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 | |
| Foggia, Italy | |
| 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 | |
| Messina, Italy | |
| 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 | |
| Milano, Italy | |
| 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 | |
| Pisa, Italy | |
| 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 | |
| Roma, Italy | |
| 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 | |
| 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 | |
| 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 | |
| Lipetsk, 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 Pharmaceuticals
Investigators
| 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
Additional Information:
Publications:
| Responsible Party: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT00422162 History of Changes |
| Other Study ID Numbers: | 10614, F1J-BI-HMES |
| Study First Received: | January 11, 2007 |
| Results First Received: | August 25, 2009 |
| Last Updated: | July 22, 2011 |
| Health Authority: | Russia: Pharmacological Committee, Ministry of Health Italy: National Monitoring Centre for Clinical Trials - Ministry of Health South Africa: National Health Research Ethics Council France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Depressive Disorder, Major Behavioral Symptoms Mood Disorders Mental Disorders Duloxetine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents Dopamine Uptake Inhibitors Dopamine Agents Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013