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Efficacy and Safety of Magnesium Vitamin B6 in First Episode Bipolar Disorder

StatusRecruiting
PhasePhase 2
Started2023-12-13
View on ClinicalTrials.gov ↗

Amendment history

2026-06-22
Study Status v8
Re-verified, no change to tracked fields
2026-01-21
Study Status, Oversight, IPDSharing v7
Primary completion date2025-12→2026-10
Completion date2025-12→2026-10
2025-05-09
Study Status, Oversight, Eligibility, IPDSharing v6
Eligibility criteria+4 characters
Inclusion Criteria: Persons between the ages of 18 and 4550 DSM V diagnosis of bipolar I disorder, onset of illness in the last 710 years Minimum of two of the following symptoms on the Hamil [...] somatic symptoms-general, somatic symptoms-gastrointestinal; with HAM-D total scores of 15 or lower. Young Mania Rating Scale (YMRS) scores of less than 15 Abi [...] ine hydrochloride or any of the other components of Magne B6 Patients taking psychostimulant medication
2024-03-28
Study Status, Eligibility v5
Eligibility criteria-142 characters
[...] s-gastrointestinal; with HAM-D total scores of 15 or lower. Moderate to extremely severe stress at screening, defined as a DASS-42 stress subscale score of >18 Young Mania Rating Scale (YMRS) scores of less than 15 Abili [...] ar type. 2 or more manic symptoms that meet DSM-V criteria. Persons currently taking antidepressants. Persons of childbearing potential who are not using a medica [...]
2023-12-15
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2025-10→2025-12
Completion date2025-10→2025-12
Start dateestimated 2023-11→confirmed 2023-12-13
Study sites0→1
Show 3 earlier versions
2023-11-16
Study Status, Outcome Measures, Contacts/Locations v3
Primary completion date2024-08→2025-10
Completion date2025-08→2025-10
Start date2023-08→2023-11
Secondary endpoints7 to 10 entries
Changes in brain energyATP Changes metabolismin markersbrain PCr Changes in brain pH Changes in brain inorganic phosphate concentration
2023-08-09
Study Status v2
Primary completion date2024-05→2024-08
Completion date2025-05→2025-08
Start date2023-05→2023-08
2023-05-16
Study Status, Study Description, Outcome Measures v1
Secondary endpoints7 entries, revised
Change in Clinical Global Impression (CGI) Scale Change in adverse events.
Study description+15 characters
[...] ipolar disorder in the early phase of illness. In addition, wethe investigators aim to assess the effects of Magnesium-vitamin B6 on brain [...]
2023-04-28
Original filing
Mclean Hospital
53 trials monitored
See 1 trial at risk
Depression
2,976 trials monitored
See 162 trials at risk
Anxiety
2,229 trials monitored
See 91 trials at risk
Bipolar Disorder
384 trials monitored
See 22 trials at risk
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.
Trial Details
NCT Number NCT05837104
Lead Sponsor Mclean Hospital
Conditions Bipolar I Disorder, Depression, Anxiety, Stress
Enrollment 40 participants
Start Date 2023-12-13
Primary Completion 2026-10 (estimated)
Study Completion 2026-10 (estimated)
Updated on ClinicalTrials.gov 2026-06-25