A Study Evaluating Duloxetine in Patients Hospitalized for Severe Depression

NCT ID: NCT00422162

Last Updated: 2011-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 339 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2008-08-31

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Duloxetine hydrochloride

Intervention Type: DRUG

60 mg once or twice a day, by mouth

Placebo

Intervention Type: DRUG

placebo capsule by mouth

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

Group Type: EXPERIMENTAL

Duloxetine hydrochloride

Intervention Type: DRUG

60 mg once or twice a day, by mouth

Placebo

Intervention Type: DRUG

placebo capsule by mouth

Interventions

Duloxetine hydrochloride

60 mg once or twice a day, by mouth

Intervention Type: DRUG

Placebo

placebo capsule by mouth

Intervention Type: DRUG

Other Intervention Names

LY248686; Cymbalta

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Eli Lilly

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Besançon, , France

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Bordeaux, , France

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Bully-les-Mines, , France

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Château-Gontier, , France

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Dijon, , France

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Dole, , France

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Fains-Véel, , France

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Jarnac, , France

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La Charité-sur-Loire, , France

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La Rochelle, , France

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Limoges, , France

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Marseille, , France

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Montberon, , France

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Montpellier, , France

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Nîmes, , France

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Paris, , France

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Saint-Dizier, , France

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Florence, , Italy

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Foggia, , Italy

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Messina, , Italy

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Milan, , Italy

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Pisa, , Italy

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Roma, , Italy

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Siena, , Italy

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Kazan', , Russia

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Lipetsk, , Russia

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Moscow, , Russia

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Nizhny Novgorod, , Russia

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Saint Petersburg, , Russia

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Saratov, , Russia

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Bryanston, , South Africa

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Cape Town, , South Africa

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George, , South Africa

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Krugersdorp, , South Africa

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Pretoria, , South Africa

Countries

France; Italy; Russia; South Africa

References

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.

Reference Type: RESULT

PMID: 20868642 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25317365 (View on PubMed)

Other Identifiers

F1J-BI-HMES

Identifier Type: OTHER

Identifier Source: secondary_id

10614

Identifier Type: -

Identifier Source: org_study_id