Major Depressive Disorder Clinical Trial
Official title:
A Multicenter, Randomized, Double-blind, Placebo-controlled, 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 | December 2015 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This is a double-blind study evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) versus placebo in the Treatment of Children and Adolescent Outpatients with Major Depressive Disorder (MDD).
| Status | Completed |
| Enrollment | 363 |
| Est. completion date | November 2015 |
| Est. primary completion date | September 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| 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 behavior or requires precaution against suicide - Not in generally healthy medical condition - History of psychosis or bipolar disorder - Seizure disorder |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Chile | Biomedica Research Group | Santiago | Region Metropolitana |
| Chile | Optima Salud | Santiago | Region Metropolitana |
| Mexico | Hospital Universitario Dr. Jose Eleuterio Gonzalez, Departamento de Psiquiatria | Monterrey | Nuevo Leon |
| United States | FutureSearch Trials | Austin | Texas |
| United States | Pharmasite Research Inc | Baltimore | Maryland |
| United States | Children's Hospital of Alabama Laboratory | Birmingham | Alabama |
| United States | The University of Alabama at Birmingham, Office of Psychiatric Research | Birmingham | Alabama |
| United States | Erie County Medical Center / State University of New York at Buffalo affiliate | Buffalo | New York |
| United States | Neuro-Behavioral Clinical Research, Inc. | Canton | Ohio |
| United States | Discovery and Wellness Center for Children/University Hospitals Case Medical Center | Cleveland | Ohio |
| United States | MCB Clinical Research Centers | Colorado Springs | Colorado |
| United States | Millennium Psychiatric Associates, LLC | Creve Coeur | Missouri |
| United States | SJS Clinical Research, Inc. | Destin | Florida |
| United States | Sarkis Clinical Trials | Gainesville | Florida |
| United States | The Zucker Hillside Hospital, North Shore-Long Island Jewish Health System | Glen Oaks | New York |
| United States | Bliss Basement Pharmacy - Hartford Hospital | Hartford | Connecticut |
| United States | Institute of Living | Hartford | Connecticut |
| United States | Institute of Living/Hartford Hospital | Hartford | Connecticut |
| United States | Sun Valley Research Center | Imperial | California |
| United States | Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida |
| United States | Eastside Therapeutic Resource | Kirkland | Washington |
| United States | Capstone Clinical Research | Libertyville | Illinois |
| United States | Premier Psychiatric Research Institute, LLC | Lincoln | Nebraska |
| United States | Northwest Behavioral Research Center | Marietta | Georgia |
| United States | Research Strategies of Memphis, LLC. | Memphis | Tennessee |
| United States | Bioscience Research, LLC. | Mount Kisco | New York |
| United States | AMR-Baber Research Inc. | Naperville | Illinois |
| United States | Sooner Clinical Research | Oklahoma City | Oklahoma |
| United States | Medical Research Group of Central Florida | Orange City | Florida |
| United States | Millenia Psychiatry & Research, Inc. | Orlando | Florida |
| United States | Alliance Research Group | Richmond | Virginia |
| United States | Virginia Commonwealth University | Richmond | Virginia |
| United States | Virginia Treatment Center | Richmond | Virginia |
| United States | Carilion Medical Center | Roanoke | Virginia |
| United States | Finger Lakes Clinical Research | Rochester | New York |
| United States | Clinical Trials of Texas, Inc. | San Antonio | Texas |
| United States | Drug:University Health Shreveport Outpatient | Shreveport | Louisiana |
| United States | Louisiana State University Health Sciences Center-Psychopharmacology Research Clinic | Shreveport | Louisiana |
| United States | Stony Brook University Medical Center, Child And Adolescent Psychiatry | Stony Brook | New York |
| United States | Clinco | Terre Haute | Indiana |
| United States | Center for Advanced Improvement | Tucson | Arizona |
| United States | Janus Center for Psychiatric Research | West Palm Beach | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Chile, Mexico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline to Week 8 in the Child Depression Rating Scale - Revised (CDRS-R): Total Score | 8 weeks | No | |
| Secondary | Clinical Global Impression Improvement (CGI-I) Score at the Week 8 visit | 8 weeks | No | |
| Secondary | Clinical Global Impression Severity Score at the Week 8 visit | 8 weeks | No | |
| Secondary | Clinical Global Impression Improvement Response (score 1 or 2) | 8 weeks | No |
| 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 |