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

ConditionsBipolar I Disorder Depression, Anxiety Stress

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-50

SponsorMclean Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Persons between the ages of 18 and 50

DSM V diagnosis of bipolar I disorder, onset of illness in the last 10 years

Minimum of two of the following symptoms on the Hamilton Rating Scale of Depression HAM-D (HAM-D, 17 item): depressed mood, feelings of guilt, anxiety-psychic, anxiety-somatic, somatic symptoms-general, somatic symptoms-gastrointestinal.

Young Mania Rating Scale (YMRS) scores of less than 15

Disqualifiers

Unable to sign informed consent.

Persons weighing over 350lbs.

Declines to participate.

Bipolar NOS, Cyclothymia, or Schizoaffective Bipolar type.

Trial design

Design model

Parallel

Treatments tested in this trial

Magnesium vitamin B6
Drug
Magnesium citrate (100mg) and Pyridoxine hydrochloride (10mg) in tablet form, taken three times daily for four weeks.
Placebo
Drug
Placebo tablet, three times daily for four weeks.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Magnesium vitamin B6Experimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Change 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

Secondary outcomes

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

Other outcomes

Change in World Health Organization Disability Assessment Schedule (WHODAS) score

Change from baseline to week 4 in World Health Organization Disability Assessment Schedule (WHODAS) scale. Scores range from 0-144; a higher score indicates greater dysfunction and disability in major life domains.

Time frame

4 weeks

Change in World Health Organization Quality of Life (WHOQOL) score

Change from baseline to week 4 in World Health Organization Quality of Life (WHOQOL) scale. Scores range from 1-130; a lower score indicates lower perceived quality of life.

Time frame

4 weeks

Change in Mg blood level

Change from baseline to week 4 in Mg blood levels.

Time frame

4 weeks

Change is Positive and Negative Syndrome Scale (PANSS) total score

Change from baseline to week 4 in Positive and Negative Syndrome Scale (PANSS) total score. Scores range from 23-161; a higher score indicates a more severe illness.

Time frame

4 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mclean Hospital

Lead sponsor

Source ClinicalTrials.gov

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