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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05837104
The ClinicalTrials.gov registry entry for NCT05837104 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 152 other Stress trials with a reported enrollment target (95% lower). The listed sponsor is Mclean Hospital, which has 140 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.