Efficacy and Safety of Magnesium Vitamin B6 in First Episode Bipolar Disorder
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
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
Treatments tested in this trial
- Magnesium vitamin B6
- Placebo
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov