Depressive Disorder, Major Clinical Trial
— ARDENTOfficial title:
Attributes of Response in Depressed Patients Switched to Treatment With Duloxetine (ARDENT Study)
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.
Status | Completed |
Enrollment | 242 |
Est. completion date | July 2009 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Male or female outpatients aged 18 years or older who meet criteria for Major Depressive Disorder (MDD). - Currently receiving a selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (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 17-Item Hamilton Depression Rating Scale (HAMD-17) at screening (Visit 1) or baseline (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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
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. | Guri City | |
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. | Seoul |
Lead Sponsor | Collaborator |
---|---|
Eli Lilly and Company |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in Brief Pain Inventory-Modified Short Form (BPI-SF) Interference Score Between Responder and Non-Responder Participants at 4 Weeks | BPI-SF interference score asks about the degree to which pain interferes with mood, walking and other physical activity, work, social activity, relations with others, and sleep. BPI-SF interference score ranges from 0 (no interference) to 10 (interferes completely). Response is defined as a >=50% reduction in the Maier subscale score from baseline. The Maier subscale (Items 1,2,7,8,9,10) represents "core" symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section. | Baseline, 4 weeks | No |
Secondary | Percentage of Participants Meeting Criteria for Response on the 17-Item Hamilton Depression Rating Scale (HAMD-17) Maier Subscale at 4 and 8 Weeks | The Maier subscale (Items 1,2,7,8,9,10) represents the "core" symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe). Response is defined as a >=50% reduction in the Maier subscale score from baseline. | Baseline, 4 weeks, 8 weeks | No |
Secondary | Change From Baseline HAMD-17 Total Score at 8 Weeks | The HAMD-17 total score measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section. | Baseline, 8 weeks | No |
Secondary | Change From Baseline HAMD-17 Core Subscale at 8 Weeks | The Core subscale (Items 1,2,3,7,8) evaluates "core" symptoms of depression. Total subscale scores range from 0 (normal) to 20 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section. | Baseline, 8 weeks | No |
Secondary | Change From Baseline HAMD-17 Maier Subscale at 8 Weeks | The Maier subscale (Items 1,2,7,8,9,10) represents the "core" symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section. | Baseline, 8 weeks | No |
Secondary | Change From Baseline HAMD-17 Anxiety/Somatization Subscale at 8 Weeks | The Anxiety/Somatization Subscale (Items 10-13, 15, 17) evaluates severity of psychic and somatic manifistations of anxiety as well as agitation. Total subscale scores range from 0 (normal) to 18 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section. | Baseline, 8 weeks | No |
Secondary | Change From Baseline HAMD-17 Retardation/Somatization Subscale at 8 Weeks | The Retardation Subscale (Items 1,7,8,14) evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation. Total subscale scores range from 0 (normal) to 14 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section. | Baseline, 8 weeks | No |
Secondary | Change From Baseline HAMD-17 Sleep Subscale at 8 Weeks | The Sleep Subscale (Items 4,5,6) evaluates initial, middle, and late insomnia. Total subscale scores range from 0 (no difficulty) to 6 (difficulty). Factors used for adjustment for least squares means are listed in 'Other relevant information' section. | Baseline, 8 weeks | No |
Secondary | Change From Baseline in the Hamilton Anxiety Rating Scale (HAMA) at 8 Weeks | 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. Factors used for adjustment for least squares means are listed in 'Other relevant information' section. | Baseline, 8 weeks | No |
Secondary | Change From Baseline in the Clinical Global Impression - Severity (CGI-Severity) Scale at 8 Weeks | 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). Factors used for adjustment for least squares means are listed in 'Other relevant information' section. | Baseline, 8 weeks | No |
Secondary | Change From Baseline in the Brief Pain Inventory - Modified Short Form (BPI-SF) Average Pain Score at 8 Weeks | A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Factors used for adjustment for least squares means are listed in 'Other relevant information' section. | Baseline, 8 weeks | No |
Secondary | Change From Baseline in Patient Global Impression - Improvement (PGI-I) Scale Score at 8 Weeks | 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). Factors used for adjustment for least squares means are listed in 'Other relevant information' section. | 8 weeks | No |
Secondary | Change From Baseline in the Sexual Functioning Questionnaire Clinical Version (CSFQ) at 4 and 8 Weeks | A 14-item patient-rated scale assesses medication-related changes in sexual activity/functioning. Items rated from 1 (never, low enjoyment/pleasure) to 5 (every day, great enjoyment/pleasure). CSFQ measures 5 dimensions of sexual behavior: pleasure; desire/frequency; desire/interest; arousal; orgasm. Lower total scores are associated with diminished sexual functioning. Total scores <=47 (men) and <=41 (women) indicate global sexual dysfunction, with all phases of sexual response cycle affected. Factors used for adjustment for least squares means are in 'Other relevant information' section. | Baseline, 4 Weeks, 8 weeks | No |
Secondary | Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) at 4 and 8 Weeks | The TSQM is a participant-reported measure that best describes how the study medication makes them feel since the last study visit, assessing perceived effectiveness, severity of side effects, and convenience. Convenience, Effectiveness, Side-Effects, and Global Satisfaction scale scores range from 0 (extremely dissatisfied) to 100 (extremely satisfied). Factors used for adjustment for least squares means are listed in 'Other relevant information' section. | Baseline, 4 weeks, 8 weeks | No |
Secondary | Change From Baseline in the Sheehan Disability Scale (SDS) at 4 and 8 Weeks | The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Factors used for adjustment for least squares means are listed in 'Other relevant information' section. | Baseline, 4 weeks, 8 weeks | No |
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