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.
After a first episode of bipolar disorder, subsequent depressive and anxiety symptoms can pose a major challenge to an individual's recovery early in the illness. Individuals often have depressive and anxiety symptoms for a significant proportion of their time. These mood and anxiety symptoms are associated with higher risk for relapse, chronicity and disability. Previous studies have shown that the combination of Magnesium-vitamin B6 has beneficial effects on stress, and depressive and anxiety symptoms. This randomized, double-blind, placebo-controlled trial will assess the benefits of Magnesium-vitamin B6 in combination with treatment as usual (standard of clinical care) on depressive and anxiety symptoms and stress in individuals with bipolar disorder in the early phase of illness. In addition, the investigators aim to assess the effects of Magnesium-vitamin B6 on brain free \[Mg2+\] and energy metabolism, observed to be altered in bipolar disorder, measured by in vivo 31P magnetic resonance spectroscopy (31P MRS). Magnesium is a promising targeted intervention for bipolar disorder given its significant effects on energy metabolism.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
Magnesium citrate (100mg) and Pyridoxine hydrochloride (10mg) in tablet form, taken three times daily for four weeks.
Placebo tablet, three times daily for four weeks.
McLean Hospital
Belmont, Massachusetts, United States
RECRUITINGChange in depressive symptoms
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.
Time frame: 4 weeks
Change in anxiety symptoms
Change from baseline to week 4 in Hamilton Anxiety Rating Scale (HAM-A) total score. Scores range from 0-56; a higher score indicates a higher level of anxiety.
Time frame: 4 weeks
Change in stress symptoms
Change from baseline to week 4 in Depression Anxiety Stress Scales (DASS-42) Stress Subscale score. Scores range from 0-42; a higher score indicates a higher level of stress.
Time frame: 4 weeks
Change in Clinical Global Impression (CGI) Scale
Change from baseline to week 4 in Clinical Global Impression (CGI) Scale. Scores range from 1-7; a higher score indicates higher severity of illness.
Time frame: 4 weeks
Change in cognitive measure
Change from baseline to week 4 in MATRICS Consensus Cognitive Battery (MCCB) Total score. Scores range from 0.00%-100.00%; a higher score indicates higher cognition.
Time frame: 4 weeks
Changes in brain ATP
Changes in ATP concentration as measured by in vivo 31P magnetic resonance spectroscopy.
Time frame: 4 weeks
Changes in brain PCr
Changes in Phosphocreatine (PCr) concentration as measured by in vivo 31P magnetic resonance spectroscopy.
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Time frame: 4 weeks
Changes in brain pH
Changes in pH as measured by in vivo 31P magnetic resonance spectroscopy.
Time frame: 4 weeks
Changes in brain inorganic phosphate concentration
Changes in inorganic phosphate (Pi) concentration as measured by in vivo 31P magnetic resonance spectroscopy.
Time frame: 4 weeks
Change in brain Mg2+ concentration
Change from baseline to week 4 in Mg2+ concentration as measured by 31P MRS.
Time frame: 4 weeks
Change in adverse events
Change from baseline to week 4 in adverse events.
Time frame: 4 weeks