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A Study Evaluating Duloxetine in Patients Hospitalized for Severe Depression

Primary Purpose

Major Depressive Disorder

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Duloxetine hydrochloride

Placebo

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Duloxetine Hydrochloride (60 mg)

Duloxetine Hydrochloride (120 mg)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From Baseline

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).

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).

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).

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).

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.

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.

Patients Reaching Remission

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

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

Number of participants using medication for anxiety and sleep disturbances.

Number of Patients With Potentially Clinically Significant Laboratory Findings

Laboratory results that were potentially clinically significant.

Discontinuations Due to Adverse Events (AE)

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

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

Change in weight = Post-baseline visit minus baseline.

Full Information

NCT ID

NCT00422162

First Posted

January 11, 2007

Last Updated

July 22, 2011

Sponsor

Eli Lilly and Company

Collaborators

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT00422162

Brief Title

A Study Evaluating Duloxetine in Patients Hospitalized for Severe Depression

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 Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Completed

Study Start Date

February 2007 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Eli Lilly and Company

Collaborators

Boehringer Ingelheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

339 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Duloxetine Hydrochloride (60 mg)

Arm Type

Experimental

Arm Description

Arm Title

Duloxetine Hydrochloride (120 mg)

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Duloxetine hydrochloride

Other Intervention Name(s)

LY248686, Cymbalta

Intervention Description

60 mg once or twice a day, by mouth

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

placebo capsule by mouth

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline to Week 4

Secondary Outcome Measure Information:

Title

Change in 6-Item Hamilton Depression Scale (HAMD-6) Total Scores From Baseline

Description

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).

Time Frame

Baseline to Weeks 1, 2, 3, 4, 6, 8

Title

Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score From Baseline

Description

Time Frame

Baseline to Weeks 1, 2, 3, 4, 6, 8

Title

Evaluation of Rescue Options Based on Changes in the Montgomery-Asberg Depression Rating Scale (MADRS) and the 6-Item Hamilton Depression Scale (HAMD-6)

Description

Time Frame

4 to 8 weeks

Title

Clinical Global Impression of Severity (CGI-S) Scores at Each Visit

Description

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).

Time Frame

Baseline, Weeks 1, 2, 3, 4, 6, 8

Title

Clinical Global Impression of Improvement (CGI-I) at Each Visit

Description

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).

Time Frame

Weeks 1, 2, 3, 4, 6, 8

Title

Patient Global Impression of Improvement (PGI-I) Score at Each Visit

Description

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).

Time Frame

Weeks 1, 2, 3, 4, 6, 8

Title

Hamilton Anxiety Scale (HAMA) Score at Baseline and Weeks 4 and 8

Description

Time Frame

Baseline and Weeks 4 and 8

Title

Percentage of Responders

Description

Time Frame

4 to 8 weeks

Title

Patients Reaching Remission

Description

Major Depressive Disorder remission was defined as a total MADRS score ≤12 at Week 8.

Time Frame

Week 8

Title

Reason for Living (RFL) Questionnaire Mean Scores at Baseline and Week 8

Description

Time Frame

Baseline and Week 8

Title

Utilization of Allowed Hypnotic and/or Anxiolytic Co-Medication

Description

Number of participants using medication for anxiety and sleep disturbances.

Time Frame

over 8 weeks

Title

Number of Patients With Potentially Clinically Significant Laboratory Findings

Description

Laboratory results that were potentially clinically significant.

Time Frame

over 8 weeks

Title

Discontinuations Due to Adverse Events (AE)

Description

Listing of adverse events (AE) that led to treatment discontinuation (DC).

Time Frame

over 8 weeks

Title

Number of Participants Experiencing High Values for Vital Signs at Any Time During the Study

Description

Time Frame

over 8 weeks

Title

Change From Baseline to Week 4 and Week 8 in Weight

Description

Change in weight = Post-baseline visit minus baseline.

Time Frame

Baseline to Weeks 4 and 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Besancon

Country

France

Facility Name

City

Bordeaux

Country

France

Facility Name

City

Bully les Mines

Country

France

Facility Name

City

Chateau-Gontier

Country

France

Facility Name

City

Dijon

Country

France

Facility Name

City

Dole

Country

France

Facility Name

City

Fains Veel

Country

France

Facility Name

City

Jarnac

Country

France

Facility Name

City

La Charite sur Loire

Country

France

Facility Name

City

La Rochelle

Country

France

Facility Name

City

Limoges

Country

France

Facility Name

City

Marseille

Country

France

Facility Name

City

Montberon

Country

France

Facility Name

City

Montpellier

Country

France

Facility Name

City

Nimes

Country

France

Facility Name

City

Paris

Country

France

Facility Name

City

Saint-Dizier

Country

France

Facility Name

City

Firenze

Country

Italy

Facility Name

City

Foggia

Country

Italy

Facility Name

City

Messina

Country

Italy

Facility Name

City

Milano

Country

Italy

Facility Name

City

Pisa

Country

Italy

Facility Name

City

Roma

Country

Italy

Facility Name

City

Siena

Country

Italy

Facility Name

City

Kazan

Country

Russian Federation

Facility Name

City

Lipetsk

Country

Russian Federation

Facility Name

City

Moscow

Country

Russian Federation

Facility Name

City

Nizhny Novgorod

Country

Russian Federation

Facility Name

City

Saratov

Country

Russian Federation

Facility Name

City

St. Petersburg

Country

Russian Federation

Facility Name

City

Bryanston

Country

South Africa

Facility Name

City

Cape Town

Country

South Africa

Facility Name

City

George

Country

South Africa

Facility Name

City

Krugersdorp

Country

South Africa

Facility Name

City

Pretoria

Country

South Africa

12. IPD Sharing Statement

Citations:

PubMed Identifier

20868642

Citation

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.

Results Reference

result

PubMed Identifier

25317365

Citation

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.

Results Reference

derived

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A Study Evaluating Duloxetine in Patients Hospitalized for Severe Depression

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