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NCT01672372 · ClinicalTrials.gov registry record · NA
The Effect of Methylated Vitamin B Complex on Depression
A NA study, sponsored by University of Miami.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT01672372: Completed NA study, sponsored by University of Miami.
NCT01672372 is a NA study that has completed, run by University of Miami. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01672372, a NA study, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study Summary
The proposed study is a 60-day, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of a methylated vitamin B complex nutritional supplement (Max Stress B™) for improving depressive and anxiety symptoms according to the Beck Depression and Anxiety Inventories, respectively, in 60 patients (18+ years of age) diagnosed with major depression or other forms of depressive disorders and an elevated level of homocysteine (\> 10 µmol/L) at baseline. Secondary outcomes will include anthropometrics for body composition, blood pressure and pulse, level of physical activity, dietary intake, and quality of life. Participants will be assessed at baseline and 30 and 60 days. The study will consist of two treatment arms: (a) vitamin B complex nutritional supplement and (b) placebo. The information obtained in this study will help in determining the efficacy of using nutritional supplements for improving the outcomes of people with depression.
Primary Outcome
Assessed by the Beck Depression Inventory II, the Beck Anxiety Inventory, SF-36v2™ Health Survey, physiological and anthropometric measures Because item 9 of the Beck Depression Inventory inquires about "Suicidal thoughts or wishes," we will immediately notify the attending physician in the Crisis facility of UM/JMH if a subject responds affirmatively to this question, which may be indicative of suicidal ideation (SI).
Interventions
- DIETARY_SUPPLEMENT Max Stress B
- DIETARY_SUPPLEMENT Placebo Max Stress B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2011-01 |
| Est. Completion | 2011-10 |
| Phase | NA |
What the finished NCT01672372 record still lists
NCT01672372 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Max Stress B is the first listed.
NCT01672372 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01672372 about?
NCT01672372 is a clinical study titled "The Effect of Methylated Vitamin B Complex on Depression". The proposed study is a 60-day, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of a methylated vitamin B complex nutritional supplement (Max Stress B™) for improving depressive and anxiety symptoms according to the Beck Depression and Anxiety Inventories, respectively, i...
What is the current status of trial NCT01672372?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2011-01. Estimated completion is 2011-10.
What interventions are being tested in trial NCT01672372?
The interventions under investigation include: Max Stress B (DIETARY_SUPPLEMENT), Placebo Max Stress B (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01672372?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01672372's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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
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