Major Depressive Disorder Clinical Trial
Official title:
A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, FLUOXETINE-REFERENCED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF DESVENLAFAXINE SUCCINATE SUSTAINED RELEASE (DVS SR) IN THE TREATMENT OF CHILDREN AND ADOLESCENT OUTPATIENTS WITH MAJOR DEPRESSIVE DISORDER
Verified date | January 2019 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a Double-blind Study Evaluating Desvenlafaxine Succinate (DVS SR) Sustained Release vs Placebo in the Treatment of Children and Adolescent Outpatients with Major Depressive Disorder (MDD).
Status | Completed |
Enrollment | 340 |
Est. completion date | March 20, 2015 |
Est. primary completion date | March 20, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 7 Years to 17 Years |
Eligibility |
Inclusion Criteria: - Age >=7 and <18 years of age - Primary diagnosis of major depressive disorder (MDD) - CDRS-R score >40 Exclusion Criteria: - History of suicidal behaviour, or requires precaution against suicide - Not in generally healthy medical condition - History of psychosis or bipolar disorder - Seizure disorder |
Country | Name | City | State |
---|---|---|---|
Mexico | Hospital Aranda de la Parra S.A. de C.V. | Leon | Guanajuato |
Mexico | CIT - Neuropsique, S.C. | Monterrey | Nuevo LEON |
United States | Atlanta Center for Medical Research | Atlanta | Georgia |
United States | Children's Hospital Colorado | Aurora | Colorado |
United States | Northwest Clinical Research Center | Bellevue | Washington |
United States | Cincinnati Children's Hospital Medical Center (New) | Cincinnati | Ohio |
United States | ATP Clinical Research, Inc. 1 | Costa Mesa | California |
United States | Harmonex Neuroscience Research, Inc. | Dothan | Alabama |
United States | Precise Research Centers | Flowood | Mississippi |
United States | Behavioral Research Specialists, LLC | Glendale | California |
United States | Dedicated Clinical Research | Goodyear | Arizona |
United States | Amedica Research Institute, Incorporated | Hialeah | Florida |
United States | Lake Charles Clinical Trials, | Lake Charles | Louisiana |
United States | Center for Psychiatry and Behavioral Medicine, Incorporated | Las Vegas | Nevada |
United States | Arkansas Psychiatric Clinic Clinical Research Trials, P.A. | Little Rock | Arkansas |
United States | Clinical Neuroscience Solutions, Inc | Memphis | Tennessee |
United States | Nina F. Wimpie, MD Pediatrics | Middleburg Heights | Ohio |
United States | North Star Medical Research, LLC | Middleburg Heights | Ohio |
United States | Rogers Center For Research And Training | Milwaukee | Wisconsin |
United States | Synergy Clinical Research Center | National City | California |
United States | Heartland Pharma Developments | North Platte | Nebraska |
United States | Cutting Edge Research Group | Oklahoma City | Oklahoma |
United States | IPS Research Company | Oklahoma City | Oklahoma |
United States | Paradigm Research Professionals, LLC | Oklahoma City | Oklahoma |
United States | Creighton University | Omaha | Nebraska |
United States | Neuropsychiatric Research Center of Orange County | Orange | California |
United States | Pacific Clinical Research Medical Group | Orange | California |
United States | Clinical Neuroscience Solutions, Inc. | Orlando | Florida |
United States | Psychiatric Associates | Overland Park | Kansas |
United States | Summit Research Network (Oregon), Incorporated | Portland | Oregon |
United States | Neuroscientific Insights | Rockville | Maryland |
United States | Midwest Research Group | Saint Charles | Missouri |
United States | St. Charles Psychiatric Associates - Midwest Research Group | Saint Charles | Missouri |
United States | Focus & Balance, LLC | San Antonio | Texas |
United States | Sharp Mesa Vista Hospital | San Diego | California |
United States | Summit Research Network (Seattle) LLC | Seattle | Washington |
United States | Institute for Behavioral Medicine | Smyrna | Georgia |
United States | University of Arizona Clinical and Translational Science Center (CATS) | Tucson | Arizona |
United States | University of Arizona College of Medicine Dept of Psychiatry | Tucson | Arizona |
United States | Grayline Clinical Drug Trials | Wichita Falls | Texas |
United States | Elite Clinical Trials, Incorporated | Wildomar | California |
United States | Kolin Research Group | Winter Park | Florida |
United States | Winter Park Memorial Hospital | Winter Park | Florida |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States, Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score | Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Adjusted mean presented. | Baseline and Week 8 | |
Secondary | Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score | A 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline. Adjusted mean presented. | Baseline and Week 8 | |
Secondary | Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8 | A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. | Baseline and Weeks 1, 2, 3, 4, 6, and 8 | |
Secondary | Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved' | A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected. | Weeks 1, 2, 3, 4, 6, and 8 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05537558 -
Precision Medicine for the Prediction of Treatment (PROMPT) Response (PROMPT)
|
||
Terminated |
NCT02192099 -
Open Label Extension for GLYX13-C-202, NCT01684163
|
Phase 2 | |
Completed |
NCT03142919 -
Lipopolysaccharide (LPS) Challenge in Depression
|
Phase 2 | |
Recruiting |
NCT05547035 -
Identification of Physiological Data by a Wearable Monitor in Subjects Suffering From Major Depression Disorders
|
N/A | |
Terminated |
NCT02940769 -
Neurobiological Effects of Light on MDD
|
N/A | |
Recruiting |
NCT05892744 -
Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression
|
Phase 4 | |
Recruiting |
NCT05537584 -
SMART Trial to Predict Anhedonia Response to Antidepressant Treatment
|
Phase 4 | |
Active, not recruiting |
NCT05061706 -
Multicenter Study of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder
|
Phase 3 | |
Completed |
NCT04479852 -
A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder
|
Phase 2 | |
Recruiting |
NCT04032301 -
Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans
|
Phase 1 | |
Recruiting |
NCT05527951 -
Enhanced Measurement-Based Care Effectiveness for Depression (EMBED) Study
|
N/A | |
Completed |
NCT03511599 -
Cycloserine rTMS Plasticity Augmentation in Depression
|
Phase 1 | |
Recruiting |
NCT04392947 -
Treatment of Major Depressive Disorder With Bilateral Theta Burst Stimulation
|
N/A | |
Recruiting |
NCT05895747 -
5-HTP and Creatine for Depression R33 Phase
|
Phase 2 | |
Recruiting |
NCT05273996 -
Predictors of Cognitive Outcomes in Geriatric Depression
|
Phase 4 | |
Recruiting |
NCT05813093 -
Interleaved TMS-fMRI in Ultra-treatment Resistant Depression
|
N/A | |
Recruiting |
NCT05135897 -
The Neurobiological Fundaments of Depression and Its Relief Through Neurostimulation Treatments
|
||
Enrolling by invitation |
NCT04509102 -
Psychostimulant Augmentation of Repetitive TMS for the Treatment of Major Depressive Disorder
|
Early Phase 1 | |
Recruiting |
NCT06026917 -
Assessing Dopamine Transporter Occupancy in the Patients With Depression Brain With Toludesvenlafaxine Hydrochloride Extended-Release Tablets Using 11C-CFT Positron Emission Tomography (PET)
|
Phase 4 | |
Recruiting |
NCT06145594 -
EMA-Guided Maintenance TMS for Depression
|
N/A |