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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

339

participants targeted

Target at P75+ for phase_4 major-depressive-disorder

Timeline

Completed

Started Feb 2007

Shorter than P25 for phase_4 major-depressive-disorder

Geographic Reach

4 countries

35 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.5 years study duration

First Submitted

Initial submission to the registry

January 11, 2007

Completed

4 days until next milestone

First Posted

Study publicly available on registry

January 15, 2007

Completed

17 days until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

October 2, 2009

Completed

Last Updated

July 26, 2011

Status Verified

July 1, 2011

Enrollment Period

1.5 years

First QC Date

January 11, 2007

Results QC Date

August 25, 2009

Last Update Submit

July 22, 2011

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

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).
Baseline to Week 4

Secondary Outcomes (15)

Change in 6-Item Hamilton Depression Scale (HAMD-6) Total Scores From Baseline
Baseline to Weeks 1, 2, 3, 4, 6, 8
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From Baseline
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)
4 to 8 weeks
Clinical Global Impression of Severity (CGI-S) Scores at Each Visit
Baseline, Weeks 1, 2, 3, 4, 6, 8
Clinical Global Impression of Improvement (CGI-I) at Each Visit
Weeks 1, 2, 3, 4, 6, 8
+10 more secondary outcomes

Study Arms (2)

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

Drug: Duloxetine hydrochlorideDrug: 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

Drug: Duloxetine hydrochlorideDrug: Placebo

Interventions

Duloxetine hydrochlorideDRUG

60 mg once or twice a day, by mouth

Also known as: LY248686, Cymbalta

Duloxetine Hydrochloride (120 mg)Duloxetine Hydrochloride (60 mg)

PlaceboDRUG

placebo capsule by mouth

Duloxetine Hydrochloride (120 mg)Duloxetine Hydrochloride (60 mg)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead
Boehringer Ingelheimcollaborator

Study Sites (35)

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, France

Location

Bordeaux, France

Location

Bully-les-Mines, France

Location

Château-Gontier, France

Location

Dijon, France

Location

Dole, France

Location

Fains-Véel, France

Location

Jarnac, France

Location

La Charité-sur-Loire, France

Location

La Rochelle, France

Location

Limoges, France

Location

Marseille, France

Location

Montberon, France

Location

Montpellier, France

Location

Nîmes, France

Location

Paris, France

Location

Saint-Dizier, France

Location

Florence, Italy

Location

Foggia, Italy

Location

Messina, Italy

Location

Milan, Italy

Location

Pisa, Italy

Location

Roma, Italy

Location

Siena, Italy

Location

Kazan', Russia

Location

Lipetsk, Russia

Location

Moscow, Russia

Location

Nizhny Novgorod, Russia

Location

Saint Petersburg, Russia

Location

Saratov, Russia

Location

Bryanston, South Africa

Location

Cape Town, South Africa

Location

George, South Africa

Location

Krugersdorp, South Africa

Location

Pretoria, South Africa

Location

Related Publications (2)

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.
PMID: 20868642RESULT
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.
PMID: 25317365DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title: Chief Medical Officer
Organization: Eli Lilly and Company

Study Officials

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
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

January 11, 2007

First Posted

January 15, 2007

Study Start

February 1, 2007

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

July 26, 2011

Results First Posted

October 2, 2009

Record last verified: 2011-07

Locations

RU(6)IT(7)ZA(5)FR(17)

A Study Evaluating Duloxetine in Patients Hospitalized for Severe Depression

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (15)

Study Arms (2)

Duloxetine Hydrochloride (60 mg)

Duloxetine Hydrochloride (120 mg)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (35)

Related Publications (2)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (15)

Study Arms (2)

Duloxetine Hydrochloride (60 mg)

Duloxetine Hydrochloride (120 mg)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (35)

Related Publications (2)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations