Switching to Duloxetine in Patients With Depression - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00696774

Purpose

The purpose of this study is to help answer the following research question: Whether switching to duloxetine improves depressed mood, when current treatment did not work well for patients with depression.

Condition	Intervention	Phase
Depressive Disorder, Major	Drug: Duloxetine	Phase IV

MedlinePlus related topics: Depression

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Attributes of Response in Depressed Patients Switched to Treatment With Duloxetine (ARDENT Study)

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Mean baseline to endpoint change in Brief Pain Inventory-Modified Short Form interference scores (Item 5) between MAIER responders and non-responders patients [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
HAMD-17 Maier Subscale (Items 1, 2, 7, 8, 9, and 10) response: defined as ≥50% reduction from baseline [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Depression severity: 17-item Hamilton Depression Rating Scale (HAMD17) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
HAMD-17 Core Subscale (Items 1, 2, 3, 7, and 8): Core symptoms of depression [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
HAMD-17 Maier Subscale (Items 1, 2, 7, 8, 9, and 10): Core symptoms of depression [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Anxiety/Somatization subscale of the HAMD-17 (Items 10, 11, 12, 13, 15, and 17) evaluates severity of psychic and somatic manifestations of anxiety, as well as agitation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Retardation/Somatization subscale (Items 1, 7, 8, and 14) evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Sleep subscale of the HAMD-17 (Items 4, 5, and 6) evaluates initial, middle, and late insomnia [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Hamilton Anxiety Rating Scale (HAM-A) measures the presence and severity of anxiety [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
CGI-Severity: Clinical Global Impression - Severity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Brief Pain Inventory: Modified Short Form (BPI-SF) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Patient Global Impression-Improvement (PGI - Improvement) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Changes in Sexual Functioning Questionnaire Clinical Version - CSFQ (Male and Female): Quality of Life [ Time Frame: At Baseline, 4 weeks post baseline and 8 weeks post baseline (or Early Discontinuation) ] [ Designated as safety issue: No ]
TSQM - Treatment Satisfaction Questionnaire for Medication [ Time Frame: At Baseline, 4 weeks post baseline and 8 weeks post baseline (or Early Discontinuation) ] [ Designated as safety issue: No ]
Sheehan Disability Scale [ Time Frame: At Baseline, 4 weeks post baseline and 8 weeks post baseline (or Early Discontinuation) ] [ Designated as safety issue: No ]

Estimated Enrollment:	240
Study Start Date:	June 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Patients who meet criteria in Study Period I will be treated with duloxetine 60 mg QD in an open-label manner for 4 weeks (Study Period II). Study Period II is considered the acute therapy period. Study Period III is a 4-week interval where patients who did not respond during Study Period II will have their duloxetine doses optimized.	Drug: Duloxetine Study Period II (Acute Therapy):60 mg capsules, QD, for 4 weeks. Study Period III (Optimization): Responder group- 60 mg capsules, QD, for 4 weeks more. Non-responder group- 120 mg capsules, QD, for 4 weeks more.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female outpatients aged 18 years or older who meet criteria for Major Depressed Disorder (Depression)
Currently receiving an SSRI or SNRI class of antidepressant for at least a month for the treatment of depression
Females of child-bearing potential (not surgically sterilized and between menarche and 1 year postmenopause) to test negative for pregnancy based on a urine pregnancy test and to agree to use a reliable method of birth control.

Exclusion Criteria:

Women who are pregnant or plan to be pregnant or are breastfeeding
To have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication
Diagnosed with treatment resistant depression
History of bipolar disorder, schizophrenia, or other psychotic disorders.
To have previously taken duloxetine that didn't work
Judged to be at serious suicidal risk in the opinion of the investigator and/or score ≥3 on Item 3 (suicide) of the HAMD17 at Visit 1 or Visit 2.
A serious medical illness that may need treatment during the study
Taking certain medications that are not allowed in this study.
To have a history of alcohol and/or drug abuse or dependence within the past year.
To have uncontrolled narrow-angle glaucoma.
To have allergic reactions to many medicines.
To have undergone "shock" therapy (Electroconvulsive Therapy) or "magnet" treatment (Transcranial Magnetic Stimulation) within the past year.
To initiate "talk therapy" (psychotherapy) just before or during the study.
To have chronic pain and you have been taking medicine for it for the last 6 months.
To have certain liver diseases.
To have kidney disease or undergoing dialysis.
Abnormal thyroid stimulating hormone (TSH) concentration

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00696774

Contacts

Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

Locations

Brazil
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Recruiting
Rio De Janeiro, Brazil, 21020-130
Contact: Eli Lilly
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Recruiting
Salvador, Brazil, 40301500
Contact: Eli Lilly
Canada, Alberta
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Recruiting
Edmonton, Alberta, Canada, T6K 3J4
Contact: Eli Lilly
Canada, British Columbia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Recruiting
Coquitlam, British Columbia, Canada, V3K3V9
Contact: Eli Lilly
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Recruiting
Vancouver, British Columbia, Canada, V6Z 2L4
Contact: Eli Lilly
Canada, Newfoundland and Labrador
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Recruiting
St. John'S, Newfoundland and Labrador, Canada, A1A 1C1
Contact: Eli Lilly
Canada, Nova Scotia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Recruiting
Sydney, Nova Scotia, Canada, B1S 2E8
Contact: Eli Lilly
Canada, Ontario
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Recruiting
Burlington, Ontario, Canada, L7R 4E2
Contact: Eli Lilly
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Recruiting
Chatham, Ontario, Canada, N7L 1B7
Contact: Eli Lilly
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Recruiting
Hamilton, Ontario, Canada, L8M 1K7
Contact: Eli Lilly
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Recruiting
Mississauga, Ontario, Canada, L5M 4N4
Contact: Eli Lilly
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Recruiting
Sudbury, Ontario, Canada, P3E 2A6
Contact: Eli Lilly
Canada, Quebec
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Recruiting
Gatineau, Quebec, Canada, J9A 1K7
Contact: Eli Lilly
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Recruiting
Montreal, Quebec, Canada, H1S3A9
Contact: Eli Lilly
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Recruiting
Quebec City, Quebec, Canada, G1R 2W8
Contact: Eli Lilly
Canada, Saskatchewan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Recruiting
Saskatoon, Saskatchewan, Canada, S7H 5M3
Contact: Eli Lilly
China
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Recruiting
Hangzhou, China, 310009
Contact: Eli Lilly
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Recruiting
Shanghai, China, 200001
Contact: Eli Lilly
Korea, Republic of
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Recruiting
Guri City, Korea, Republic of, 471-701
Contact: Eli Lilly
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Recruiting
Seoul, Korea, Republic of, 136705
Contact: Eli Lilly

Sponsors and Collaborators

Eli Lilly and Company

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

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	12349, F1J-CR-S022
Study First Received:	June 11, 2008
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00696774
Health Authority:	Brazil: National Health Surveillance Agency; Canada: Health Canada; China: State Food and Drug Administration; South Korea: Korea Food and Drug Administration (KFDA)

Study placed in the following topic categories:

Dopamine
Depression
Mental Disorders
Mood Disorders
Depressive Disorder, Major

Depressive Disorder
Serotonin
Duloxetine
Behavioral Symptoms

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs

Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 15, 2009