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NCT05837104 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Magnesium Vitamin B6 in First Episode Bipolar Disorder
A Phase 2 study of Stress and Depression, Anxiety, sponsored by Mclean Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT05837104: Recruiting Phase 2 study of Stress and Depression, Anxiety, sponsored by Mclean Hospital.
NCT05837104 is a Phase 2 study of Stress and Depression, Anxiety that is actively recruiting participants, run by Mclean Hospital. The registered enrollment target is 40 participants, below the 786-participant average among 152 other Stress trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05837104, a Phase 2 study of Stress and Depression, Anxiety, is actively recruiting participants, sponsored by Mclean Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a randomized, double-blind, placebo-controlled proof-of-concept clinical trial to assess the efficacy and safety of Magnesium-vitamin B6in combination with treatment as usual for treating symptoms of depression, stress, and anxiety in patients with first episode bipolar I disorder.
Primary Outcome
Change from baseline to week 4 in Hamilton Rating Scale for Depression (HAM-D) total score. Scores range from 0-52; a higher score indicates a higher level of depression.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Magnesium vitamin B6
Study Locations (1)
Massachusetts
- McLean Hospital - Belmont
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2023-12-13 |
| Est. Completion | 2026-10 |
| Phase | Phase 2 |
What NCT05837104 shows while recruiting
NCT05837104 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 786-participant average among 152 other Stress trials with a reported enrollment target (95% lower).
The record links to 3 conditions, with Stress appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05837104 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05837104 about?
NCT05837104 is a clinical study titled "Efficacy and Safety of Magnesium Vitamin B6 in First Episode Bipolar Disorder". This is a randomized, double-blind, placebo-controlled proof-of-concept clinical trial to assess the efficacy and safety of Magnesium-vitamin B6in combination with treatment as usual for treating symptoms of depression, stress, and anxiety in patients with first episode bipolar I disorder.
What is the current status of trial NCT05837104?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2023-12-13. Estimated completion is 2026-10.
What conditions does trial NCT05837104 study?
This clinical trial studies the following conditions: Stress, Depression, Anxiety, Bipolar I Disorder.
What interventions are being tested in trial NCT05837104?
The interventions under investigation include: Placebo (DRUG), Magnesium vitamin B6 (DRUG).
Who is sponsoring clinical trial NCT05837104?
This trial is sponsored by Mclean Hospital, which has 140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05837104 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stress
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 NCT05837104's enrollment target sits among peer trials
40 117th of 152 higher than 31 of 152 other Stress trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stress 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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