Depressive Disorder, Major Clinical Trial
Official title:
Duloxetine Versus Placebo in the Prevention of Recurrence of Major Depressive Disorder
| Verified date | July 2009 |
| Source | Eli Lilly and Company |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to assess the efficacy and safety of duloxetine compared with placebo in the prevention of depressive recurrences among patients with recurrent major depressive disorder.
| Status | Completed |
| Enrollment | 514 |
| Est. completion date | January 2008 |
| Est. primary completion date | January 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patient must be at least 18 years old. - Patient must be diagnosed with depression and have had previous episodes of depression. - Patient must sign informed consent. Exclusion Criteria: - Female and pregnant or breastfeeding. - History of bipolar disorder, schizophrenia, or other psychotic disorders. - Suffer from a serious medical illness (other than depression) or abnormal laboratory result that would require a change in medication, intervention, or hospitalization. - Have been treated with a medication called monoamine oxidase inhibitor (MAOI) within 14 days of the start of the study, or potential need to use a MAOI within 5 days of finishing the study. - Have taken an antidepressant called fluoxetine within 30 days of the start of the study. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Angouleme | |
| France | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Douai | |
| France | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Fains | |
| France | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | La Rochelle | |
| France | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lille | |
| France | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Nimes | |
| France | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Roubaix | |
| France | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Strasbourg | |
| Germany | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Berlin | |
| Germany | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ellwangen | |
| Germany | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hamburg | |
| Germany | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Hildesheim | |
| Germany | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Leipzig | |
| Germany | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Munchen | |
| Germany | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Wurzburg | |
| Italy | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Catania | |
| Italy | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Ferrara | |
| Italy | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Firenze | |
| Italy | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Parma | |
| Italy | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Roma | |
| Italy | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Torino | |
| Russian Federation | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Moscow | |
| Russian Federation | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | St. Petersburg | |
| Russian Federation | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Village Nikolskoe | |
| Sweden | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Halmstad | |
| Sweden | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Lund | |
| Sweden | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Malmo | |
| Sweden | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Stockholm | |
| Sweden | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Sundsvall | |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Baltimore | Maryland |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Brooklyn | New York |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Gaithersburg | Maryland |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Newport Beach | California |
| United States | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Sherman Oaks | California |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company | Boehringer Ingelheim |
United States, France, Germany, Italy, Russian Federation, Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants With Depressive Recurrence After Time (t) in Days | Every Visit from Week 34 up to Week 86 (Maintenance Phase) | No | |
| Secondary | Recurrence Count | Every Visit from Week 35 up to Week 86 (Maintenance Phase) | No | |
| Secondary | Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days | Every Visit from Week 34 up to Week 86 (Maintenance Phase) | No | |
| Secondary | Loss of Response at Any Time | Every Visit from Week 35 up to Week 86 (Maintenance Phase) | No | |
| Secondary | Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Acute and Continuation Phases | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | No | |
| Secondary | Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Maintenance Phase | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | No | |
| Secondary | Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Acute and Continuation Phases | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | No | |
| Secondary | Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Maintenance Phase | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | No | |
| Secondary | Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Acute and Continuation Phases | Week 10 (Acute) and Week 34 (Continuation) | No | |
| Secondary | Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Maintenance Phase | Week 86 (Maintenance Phase) | No | |
| Secondary | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | No | |
| Secondary | Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Maintenance Phase | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | No | |
| Secondary | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | No | |
| Secondary | Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Maintenance Phase | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | No | |
| Secondary | Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Acute and Continuation Phases | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | No | |
| Secondary | Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Maintenance Phase | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | No | |
| Secondary | Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | No | |
| Secondary | Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Maintenance Phase | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | No | |
| Secondary | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | No | |
| Secondary | Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | No | |
| Secondary | Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Acute and Continuation Phases | Week 0 through Week10 (Acute) through Week 34 (Continuation) | No | |
| Secondary | Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Maintenance Phase | Week 34 through Week 86 (Maintenance Phase) | No | |
| Secondary | Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Acute and Continuation Phases | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | No | |
| Secondary | Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Maintenance Phase | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | No | |
| Secondary | Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Acute and Continuation Phase | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | No | |
| Secondary | Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Maintenance Phase | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | No | |
| Secondary | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males) | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | Yes | |
| Secondary | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females) | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | Yes | |
| Secondary | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Males) | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | Yes | |
| Secondary | Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Females) | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | Yes | |
| Secondary | Vital Signs - Change From Baseline to Endpoint in Weight - Acute and Continuation Phases | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | Yes | |
| Secondary | Vital Signs - Change From Baseline to Endpoint in Weight - Maintenance Phase | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | Yes | |
| Secondary | Vital Signs - Change From Baseline to Endpoint in Pulse - Acute and Continuation Phases | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | Yes | |
| Secondary | Vital Signs - Change From Baseline to Endpoint in Pulse - Maintenance Phase | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | Yes | |
| Secondary | Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Acute and Continuation Phases | Week 0 and Week 10 (Acute) and Week 34 (Continuation) | Yes | |
| Secondary | Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Maintenance Phase | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | Yes | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Acute Phase | Week 0 and Week 10 | Yes | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Acute Phase | Week 0 and Week 10 | Yes | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Chloride - Acute Phase | Week 0 and Week 10 | Yes | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Eosinophils - Acute Phase | Week 0 and Week 10 | Yes | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Acute Phase | Week 0 and Week 10 | Yes | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Acute Phase | Week 0 and Week 10 | Yes | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Acute Phase | Week 0 and Week 10 | Yes | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Platelet Count - Acute Phase | Week 0 and Week 10 | Yes | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Sodium - Acute Phase | Week 0 and Week 10 | Yes | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Acute Phase | Week 0 and Week 10 | Yes | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Uric Acid - Acute Phase | Week 0 and Week 10 | Yes | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Continuation Phase | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | Yes | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bicarbonate, HCO3 - Continuation Phase | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | Yes | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Direct - Continuation Phase | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | Yes | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Total - Continuation Phase | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | Yes | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Continuation Phase | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | Yes | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Erythrocyte Count - Continuation Phase | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | Yes | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Continuation Phase | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | Yes | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Continuation Phase | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | Yes | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Continuation Phase | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | Yes | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Leukocyte Count - Continuation Phase | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | Yes | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Low Density Lipoprotein (LDL) Cholesterol (Direct) - Continuation Phase | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | Yes | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Hemoglobin - Continuation Phase | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | Yes | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Volume (MCV) - Continuation Phase | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | Yes | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Monocytes - Continuation Phase | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | Yes | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Continuation Phase | Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) | Yes | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Alanine Aminotransferase (ALT) - Maintenance Phase | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | Yes | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Maintenance Phase | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | Yes | |
| Secondary | Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Glucose - Maintenance Phase | Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) | Yes | |
| Secondary | Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase | Every Visit from Week 0 up to Week 10 (Acute) | Yes | |
| Secondary | Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase | Every Visit from Week 10 up to Week 34 (Continuation) | Yes |
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