Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00955955 · ClinicalTrials.gov registry record · Phase 4
Study of 6(S)-5-MTHF Among Selective Serotonin Reuptake Inhibitor-Resistant Outpatients With Major Depressive Disorder
A Phase 4 study of Depression, sponsored by George I. Papakostas.
- Completed
- Registry status
- Phase 4
- Development phase
- 75
- Enrollment target
- 6
- Study locations
NCT00955955: Completed Phase 4 study of Depression, sponsored by George I. Papakostas.
NCT00955955 is a Phase 4 study of Depression that has completed, run by George I. Papakostas. The registered enrollment target is 75 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (90% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00955955, a Phase 4 study of Depression, has completed, sponsored by George I. Papakostas.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 75 participants
- Enrollment target
- 6
- Study locations
Study Summary
The purpose of the study is to test whether oral 6(S)-5-MTHF (Deplin) is safe and effective in relieving depression when it is added to standard kinds of antidepressants called serotonin reuptake inhibitors (SSRIs).
Primary Outcome
The HAM-D-17 is a multiple choice questionnaire that clinicians may use to rate the severity of a patient's major depression. Items are scored on a scale of zero to four and higher scores indicate greater impairment. This scale is scored by summing the scores on each item and scores can range from 0-68. When assessing changes in HAMD score, negative changes indicate improvement (i.e. the score has decreased) and positive scores indicate a worsening of symptoms (i.e. scores have increased).
Conditions Studied
Interventions
- OTHER Placebo
- OTHER 6(S)-5-MTHF(Deplin)
Study Locations (6)
California
- University of California San Diego School of Medicine - San Diego
Illinois
- Rush University Medical Center, Psychiatric Medicine Associates, LLC - Chicago
Massachusetts
- Massachusetts General Hospital - Boston
Ohio
- University of Cincinnati, College of Medicine - Cincinnati
Pennsylvania
- University of Pennsylvania - Philadelphia
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2009-07 |
| Est. Completion | 2011-04 |
| Phase | Phase 4 |
What the finished NCT00955955 record still lists
NCT00955955 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 786-participant average among 679 other Depression trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00955955 lists 6 locations in 6 states (California, Illinois, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT00955955 about?
NCT00955955 is a clinical study titled "Study of 6(S)-5-MTHF Among Selective Serotonin Reuptake Inhibitor-Resistant Outpatients With Major Depressive Disorder". The purpose of the study is to test whether oral 6(S)-5-MTHF (Deplin) is safe and effective in relieving depression when it is added to standard kinds of antidepressants called serotonin reuptake inhibitors (SSRIs).
What is the current status of trial NCT00955955?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 75 participants. The study started on 2009-07. Estimated completion is 2011-04.
What conditions does trial NCT00955955 study?
This clinical trial studies the following conditions: Depression.
What interventions are being tested in trial NCT00955955?
The interventions under investigation include: Placebo (OTHER), 6(S)-5-MTHF(Deplin) (OTHER).
Who is sponsoring clinical trial NCT00955955?
This trial is sponsored by George I. Papakostas, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00955955 being conducted?
This trial has 6 study locations across California, Illinois, Massachusetts, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00955955's enrollment target sits among peer trials
75 387th of 679 higher than 288 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Identifying and Treating Depression in the Orthopaedic Trauma Population
RECRUITING · Phase 4
-
Dopaminergic Therapy for Anhedonia - 2
RECRUITING · Phase 4
-
Examining the Effects of Estradiol on Neural and Molecular Response to Reward
RECRUITING · Phase 4
-
Buspirone and Melatonin for Depression Following Traumatic Brain Injury
RECRUITING · Phase 4
-
Processes and Circuitry Underlying Threat Sensitivity as a Treatment Target for Co-morbid Anxiety and Depression
RECRUITING · Phase 4
-
Determining Optimal Treatment Sequences in Anxious Depression (DOTS-AD)
RECRUITING · Phase 4
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01535430 · 75 participants
Assessment of Eloquent Function in Brain Tumor Patients
- NCT01542879 · 75 participants · Phase 1
Development of Radiation Free Whole Body Magnetic Resonance (MR) Imaging Technique for Staging Children With Cancer
- NCT02232191 · 75 participants · Phase 2
Immunologic Response to Pneumococcal Polysaccharide Vaccine in Splenic Injury Patients
- NCT02754544 · 75 participants · NA
Electrocorticography in Mapping Functional Brain Areas During Surgery in Patients With Brain Tumors
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia