Major Depressive Disorder Clinical Trial
— LVM-MD-04Official title:
A Long-Term, Open-label Extension Study of F2695 SR in Adult Patients With Major Depressive Disorder
| Verified date | August 2012 |
| Source | Forest Laboratories |
| 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 evaluate the long- term safety of F2695-SR in the treatment of adults with major depressive disorder.
| Status | Completed |
| Enrollment | 828 |
| Est. completion date | |
| Est. primary completion date | June 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Completed 1 of the lead-in studies LVM-MD-01, LVM-MD-02, or LVM-MD-03 - Have normal examination findings at the final visit of the lead-in study - Have a negative serum pregnancy test at the final visit of the lead-in study if a woman of child-bearing potential Exclusion Criteria: - Any exclusionary psychiatric or medical condition that developed during the lead in study - Patients considered a suicide risk - Women who are pregnant, breastfeeding, or planning to become during the study OR are sexually active and not currently using a medically acceptable method of contraception |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Forest Investigative Site 54 | Allentown | Pennsylvania |
| United States | Forest Investigative Site 70 | Atlanta | Georgia |
| United States | Forest Investigative Site 1 | Baltimore | Maryland |
| United States | Forest Investigative Site 19 | Bellevue | Washington |
| United States | Forest Investigative Site 31 | Beverly Hills | California |
| United States | Forest Investigative Site 57 | Boca Raton | Florida |
| United States | Forest Investigative Site 60 | Boca Raton | Florida |
| United States | Forest Investigative Site 42 | Brooklyn | New York |
| United States | Forest Investigative Site 51 | Brooklyn | New York |
| United States | Forest Investigative Site 25 | Canton | Ohio |
| United States | Forest Investigative Site 35 | Cherry Hill | New Jersey |
| United States | Forest Investigative Site 33 | Chicago | Illinois |
| United States | Forest Investigative Site 18 | Coral Springs | Florida |
| United States | Forest Investigative Site 3 | Costa Mesa | California |
| United States | Forest Investigative Site 30 | Cromwell | Connecticut |
| United States | Forest Investigative Site 20 | Dallas | Texas |
| United States | Forest Investigative Site 47 | Dallas | Texas |
| United States | Forest Investigative Site 10 | Dayton | Ohio |
| United States | Forest Investigative Site 28 | Denver | Colorado |
| United States | Forest Investigative Site 36 | Denver | Colorado |
| United States | Forest Investigative Site 55 | Dothan | Alabama |
| United States | Forest Investigative Site 15 | East Lansing | Michigan |
| United States | Forest Investigative Site 12 | Encino | California |
| United States | Forest Investigative Site 6 | Escondido | California |
| United States | Forest Investigative Site 32 | Fall River | Massachusetts |
| United States | Forest Investigative Site 34 | Fort Myers | Florida |
| United States | Forest Investigative Site 64 | Gainesville | Florida |
| United States | Forest Investigative Site 2 | Glen Burnie | Maryland |
| United States | Forest Investigative Site 45 | Hallandale Beach | Florida |
| United States | Forest Investigative Site 65 | Highlands Ranch | Colorado |
| United States | Forest Investigative Site 23 | Hoffman Estates | Illinois |
| United States | Forest Investigative Site 63 | Indianapolis | Indiana |
| United States | Forest Investigative Site 17 | Jacksonville | Florida |
| United States | Forest Investigative Site 44 | Lincoln | Rhode Island |
| United States | Forest Investigative Site 14 | Media | Pennsylvania |
| United States | Forest Investigative Site 26 | Memphis | Tennessee |
| United States | Forest Investigative Site 4 | Mount Kisco | New York |
| United States | Forest Investigative Site 16 | New York | New York |
| United States | Forest Investigative Site 39 | New York | New York |
| United States | Forest Investigative Site 43 | Norristown | Pennsylvania |
| United States | Forest Investigative Site 50 | Oak Brook | Illinois |
| United States | Forest Investigative Site 53 | Ocala | Florida |
| United States | Forest Investigative Site 22 | Oceanside | California |
| United States | Forest Investigative Site 56 | Oklahoma City | Oklahoma |
| United States | Forest Investigative Site 67 | Oklahoma City | Oklahoma |
| United States | Forest Investigative Site 13 | Orlando | Florida |
| United States | Forest Investigative Site 61 | Orlando | Florida |
| United States | Forest Investigative Site 24 | Philadelphia | Pennsylvania |
| United States | Forest Investigative Site 40 | Portland | Oregon |
| United States | Forest Investigative Site 71 | Prairie Village | Kansas |
| United States | Forest Investigative Site 46 | Raleigh | North Carolina |
| United States | Forest Investigative Site 37 | Rockville | Maryland |
| United States | Forest Investigative Site 58 | Salem | Oregon |
| United States | Forest Investigative Site 62 | San Antonio | Texas |
| United States | Forest Investigative Site 7 | San Antonio | Texas |
| United States | Forest Investigative Site 29 | Scottsdale | Arizona |
| United States | Forest Investigative Site 41 | Seattle | Washington |
| United States | Forest Investigative Site 38 | Sherman Oaks | California |
| United States | Forest Investigative Site 52 | Shreveport | Louisiana |
| United States | Forest Investigative Site 66 | Smyrna | Georgia |
| United States | Forest Investigative Site 69 | Spokane | Washington |
| United States | Forest Investigative Site 9 | Staten Island | New York |
| United States | Forest Investigative Site 68 | Virginia Beach | Virginia |
| United States | Forest Investigative Site 27 | West Palm Beach | Florida |
| United States | Forest Investigative Site 5 | Wichita | Kansas |
| United States | Forest Investigative Site 21 | Willingboro | New Jersey |
| United States | Forest Investigative Site 59 | Winter Park | Florida |
| United States | Forest Investigative Site 8 | Woodstock | Vermont |
| Lead Sponsor | Collaborator |
|---|---|
| Forest Laboratories |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Adverse events, clinical laboratory tests, vital sign measurements, electrocardiograms, physical examinations, Columbia-Suicide Severity Rating Scale | 48 weeks | Yes |
| 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 |