Major Depressive DisorderPhase 4NCT00422162

A Study Evaluating Duloxetine in Patients Hospitalized for Severe Depression

A Phase 4 study testing Duloxetine hydrochloride in people with Major Depressive Disorder, run by Eli Lilly and Company at 35 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Major Depressive Disorder
What is being tested?: Duloxetine hydrochloride
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: 35 sitesin 4 countries
Study dates: Feb 2007to 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 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.

Who cannot join

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

Trial locations and contacts

35 sites in 4 countries.

Country

City, postcode or hospital

35 sites in 4 countries

France17 sites

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
Besançon
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Bordeaux
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Bully-les-Mines
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Château-Gontier
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Dijon
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Dole
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Fains-Véel
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Jarnac
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La Charité-sur-Loire
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La Rochelle
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Limoges
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Marseille
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Montberon
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Montpellier
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Nîmes
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Paris
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Saint-Dizier

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Italy7 sites

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Florence
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Foggia
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Messina
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Milan
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Pisa
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Roma
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Siena

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Russia6 sites

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'
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Lipetsk
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Moscow
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Nizhny Novgorod
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Saint Petersburg
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Saratov

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South Africa5 sites

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Bryanston
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Cape Town
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George
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Krugersdorp
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Pretoria

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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 Per Day in Patients Hospitalized for Severe Depression

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.

Conditions: Major Depressive Disorder
Being tested: Duloxetine hydrochloride, 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.

Duloxetine hydrochlorideDrug
Also called LY248686, Cymbalta
60 mg once or twice a day, by mouth
PlaceboDrug
placebo capsule by mouth

Study groups in NCT00422162
Study group	Role	What they receive
Duloxetine Hydrochloride (60 mg)	Experimental	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 Receives: Drug: Duloxetine hydrochloride; Drug: Placebo
Duloxetine Hydrochloride (120 mg)	Experimental	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 Receives: Drug: Duloxetine hydrochloride; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline to 4 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
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).
Measured: Baseline to Week 4

Secondary outcomes (15)

Change in 6-Item Hamilton Depression Scale (HAMD-6) Total Scores From Baseline
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).
Measured: Baseline to Weeks 1, 2, 3, 4, 6, 8
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From Baseline
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).
Measured: Baseline to Weeks 1, 2, 3, 4, 6, 8
Evaluation of Rescue Options Based on Changes in the Montgomery-Asberg Depression Rating Scale (MADRS) and the 6-Item Hamilton Depression Scale (HAMD-6)
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).
Measured: 4 to 8 weeks
Clinical Global Impression of Severity (CGI-S) Scores at Each Visit
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).
Measured: Baseline, Weeks 1, 2, 3, 4, 6, 8
Clinical Global Impression of Improvement (CGI-I) at Each Visit
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).
Measured: Weeks 1, 2, 3, 4, 6, 8
Patient Global Impression of Improvement (PGI-I) Score at Each Visit
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).
Measured: Weeks 1, 2, 3, 4, 6, 8
Hamilton Anxiety Scale (HAMA) Score at 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.
Measured: Baseline and Weeks 4 and 8
Percentage of Responders
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.
Measured: 4 to 8 weeks
Patients Reaching Remission
Major Depressive Disorder remission was defined as a total MADRS score ≤12 at Week 8.
Measured: Week 8
Reason for Living (RFL) Questionnaire Mean Scores at 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.
Measured: Baseline and Week 8
Utilization of Allowed Hypnotic and/or Anxiolytic Co-Medication
Number of participants using medication for anxiety and sleep disturbances.
Measured: over 8 weeks
Number of Patients With Potentially Clinically Significant Laboratory Findings
Laboratory results that were potentially clinically significant.
Measured: over 8 weeks
Discontinuations Due to Adverse Events (AE)
Listing of adverse events (AE) that led to treatment discontinuation (DC).
Measured: over 8 weeks
Number of Participants Experiencing High Values for Vital Signs at Any Time During the Study
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.
Measured: over 8 weeks
Change From Baseline to Week 4 and Week 8 in Weight
Change in weight = Post-baseline visit minus baseline.
Measured: Baseline to Weeks 4 and 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2007Aug 2008

First posted15 Jan 2007 (estimated)
Study startFeb 2007
Primary completionAug 2008
Study completionAug 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.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 339 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00422162
Sponsor's protocol ID: 10614
Other IDs: F1J-BI-HMES
Status last verified: Jul 2011
First submitted: 11 Jan 2007
Last updated: 26 Jul 2011
Results posted: Yes, on ClinicalTrials.gov

Publications

Brecht S, Desaiah D, Marechal ES, Santini AM, Podhorna J, Guelfi JD. Efficacy and safety of duloxetine 60 mg and 120 mg daily in patients hospitalized for severe depression: a double-blind randomized trial. J Clin Psychiatry. 2011 Aug;72(8):1086-94. doi: 10.4088/JCP.09m05723blu. Epub 2010 Sep 21.
PubMed 20868642
Demyttenaere K, Desaiah D, Raskin J, Cairns V, Brecht S. Suicidal thoughts and reasons for living in hospitalized patients with severe depression: post-hoc analyses of a double-blind randomized trial of duloxetine. Prim Care Companion CNS Disord. 2014;16(3):PCC.13m01591. doi: 10.4088/PCC.13m01591. Epub 2014 May 1.
PubMed 25317365

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2011. 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 Per Day in Patients Hospitalized for Severe Depression
ClinicalTrials.gov ID: NCT00422162
Acronym / sponsor ID: 10614
Conditions: Major Depressive Disorder
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 339 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: Boehringer Ingelheim
Study start: Feb 2007
Primary completion: Aug 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 15 Jan 2007 (estimated)
Results: Posted 2 Oct 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Duloxetine Hydrochloride (60 mg)	Experimental	Drug: Duloxetine hydrochloride, Drug: PlaceboUp 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
Duloxetine Hydrochloride (120 mg)	Experimental	Drug: Duloxetine hydrochloride, Drug: PlaceboUp 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (6 listed)

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.

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 hydrochlorideAlso: LY248686, Cymbalta60 mg once or twice a day, by mouth	Drug	Duloxetine Hydrochloride (120 mg), Duloxetine Hydrochloride (60 mg)
Placeboplacebo capsule by mouth	Drug	Duloxetine Hydrochloride (120 mg), Duloxetine Hydrochloride (60 mg)

Primary outcome

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).

15 secondary outcomes

Change in 6-Item Hamilton Depression Scale (HAMD-6) Total Scores From Baseline
Time frame: Baseline to Weeks 1, 2, 3, 4, 6, 8
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From Baseline
Time frame: Baseline to Weeks 1, 2, 3, 4, 6, 8
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
Clinical Global Impression of Severity (CGI-S) Scores at Each Visit
Time frame: Baseline, Weeks 1, 2, 3, 4, 6, 8
Clinical Global Impression of Improvement (CGI-I) at Each Visit
Time frame: Weeks 1, 2, 3, 4, 6, 8
Patient Global Impression of Improvement (PGI-I) Score at Each Visit
Time frame: Weeks 1, 2, 3, 4, 6, 8
Hamilton Anxiety Scale (HAMA) Score at Baseline and Weeks 4 and 8
Time frame: Baseline and Weeks 4 and 8
Percentage of Responders
Time frame: 4 to 8 weeks
Patients Reaching Remission
Time frame: Week 8
Reason for Living (RFL) Questionnaire Mean Scores at Baseline and Week 8
Time frame: Baseline and Week 8
Utilization of Allowed Hypnotic and/or Anxiolytic Co-Medication
Time frame: over 8 weeks
Number of Patients With Potentially Clinically Significant Laboratory Findings
Time frame: over 8 weeks
Discontinuations Due to Adverse Events (AE)
Time frame: over 8 weeks
Number of Participants Experiencing High Values for Vital Signs at Any Time During the Study
Time frame: over 8 weeks
Change From Baseline to Week 4 and Week 8 in Weight
Time frame: Baseline to Weeks 4 and 8

Results and safety

Results posted to the registry on 2 Oct 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Duloxetine (60 mg)	167	143
Duloxetine (120 mg)	172	142

Primary outcome: Change From Baseline to 4 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

Time frame: Baseline to Week 4. Mean (Standard Deviation). Unit: units on a scale

Measure	Duloxetine (60 mg) n = 166	Duloxetine (120 mg) n = 170
Baseline	36.1 (4.0)	36.0 (4.6)
Change from Baseline	-20.1 (10.6)	-19.9 (10.0)

Duloxetine (60 mg) vs Duloxetine (120 mg): p = 0.88, ANCOVA

Population analysed: All randomized participants who received at least one dose of study drug; had baseline and at least one post-baseline value. Last observation carried forward.

15 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Duloxetine (60 mg)	7 of ?	95 of ?	Not reported
Duloxetine (120 mg)	6 of ?	85 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20868642Brecht S, Desaiah D, Marechal ES, Santini AM, Podhorna J, Guelfi JD. Efficacy and safety of duloxetine 60 mg and 120 mg daily in patients hospitalized for severe depression: a double-blind randomized trial. J Clin Psychiatry. 2011 Aug;72(8):1086-94. doi: 10.4088/JCP.09m05723blu. Epub 2010 Sep 21.
Derived from this study: PubMed 25317365Demyttenaere K, Desaiah D, Raskin J, Cairns V, Brecht S. Suicidal thoughts and reasons for living in hospitalized patients with severe depression: post-hoc analyses of a double-blind randomized trial of duloxetine. Prim Care Companion CNS Disord. 2014;16(3):PCC.13m01591. doi: 10.4088/PCC.13m01591. Epub 2014 May 1.
Lilly Clinical Trial RegistryLink 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.

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) study director

Eli Lilly and Company

35 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Duloxetine hydrochloride in people with Major Depressive Disorder, run by Eli Lilly and Company at 35 sites in 4 countries.

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 5 inclusion and 6 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 26 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in France, Italy, Russia, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

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 2 Oct 2009). 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 From Baseline to 4 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (time frame: Baseline to Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00422162, which also lists 2 linked publications.

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 26 Jul 2011.