Major Depressive Disorder Clinical Trial
— MOONSTONEOfficial title:
A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained-Release (SEROQUEL®) as Monotherapy in the Treatment of Patients With MDD
Verified date | March 2009 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This study is to evaluate that (SEROQUEL®) quetiapine sustained-release is efficacious and safe in the treatment of patients with MDD.
Status | Completed |
Enrollment | 600 |
Est. completion date | May 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Patient has a documented clinical diagnosis of Major Depressive Disorder. - Be able to understand and comply with the requirements of the study. - Able to understand and provide written informed consent Exclusion Criteria: - Patients (female) must not be pregnant or lactating - Current or past diagnosis of stroke or transient ischemic attack (TIA). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Research Site | Atlanta | Georgia |
United States | Research Site | Austin | Texas |
United States | Research Site | Bellevue | Washington |
United States | Research Site | Brooklyn | New York |
United States | Research Site | Brown Deer | Wisconsin |
United States | Research Site | Charleston | West Virginia |
United States | Research Site | Cherry Hill | New Jersey |
United States | Research Site | Cincinnati | Ohio |
United States | Research Site | Clementon | New Jersey |
United States | Research Site | Dallas | Texas |
United States | Research Site | Denver | Colorado |
United States | Research Site | Eagle | Idaho |
United States | Research Site | Farmington Hills | Michigan |
United States | Research Site | Jacksonville | Florida |
United States | Research Site | Las Vegas | Nevada |
United States | Research Site | Little Rock | Arkansas |
United States | Research Site | Memphis | Tennessee |
United States | Research Site | New York City | New York |
United States | Research Site | Newport Beach | California |
United States | Research Site | Norristown | Pennsylvania |
United States | Research Site | Northridge | California |
United States | Research Site | Norwich | Connecticut |
United States | Research Site | Oak Brook | Illinois |
United States | Research Site | Oceanside | California |
United States | Research Site | Portland | Oregon |
United States | Research Site | Raleigh | North Carolina |
United States | Research Site | San Antonio | Texas |
United States | Research Site | Santa Ana | California |
United States | Research Site | Seattle | Washington |
United States | Research Site | Shreveport | Louisiana |
United States | Research Site | Smyrna | Georgia |
United States | Research Site | St. Louis | Missouri |
United States | Research Site | Staten Island | New York |
United States | Research Site | Tulsa | Oklahoma |
United States | Research Site | Washington | District of Columbia |
United States | Research Site | Wichita | Kansas |
United States | Research Site | Winter Park | Florida |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from randomization to Week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score | |||
Secondary | Change from randomization to each assessment in the MADRS total score | |||
Secondary | MADRS response, defined as a =50% reduction from randomization in the MADRS total score at Week 6 |
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 |
NCT06145594 -
EMA-Guided Maintenance TMS for Depression
|
N/A | |
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 |