Sensoril(Ashwaganhda)for Bipolar Disorder
Condition: Bipolar I Disorder; Bipolar II Disorder; Bipolar Disorder NOS
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators hypothesis is that oral Sensoril® (as compared to placebo) will enhance
      cognitive abilities (specifically measures of attention, executive function, working memory,
      and visuospatial ability) in persons with bipolar disorder. Secondarily, the investigators
      hypothesize there will be secondary improvements in residual mood/anxiety symptoms, and
      metabolic indices, if impaired (fasting blood glucose and lipids).

      The investigators aim to test these hypotheses by conducting a randomized, placebo
      controlled, add on treatment trial of Sensoril® (added to existing mood stabilizer treatment)
      recruiting 60 subjects with DSM IV-TR bipolar disorder for a period of 8 weeks. Measures of
      cognition, psychopathology and laboratory indices will be utilized for evaluating primary and
      secondary outcomes, along with safety assessments.
    

Detailed description: 
      OBJECTIVE:

      To evaluate if Sensoril® treatment of persons with bipolar illness will improve their
      cognitive performance and if it will improve residual mood/anxiety symptoms and impaired
      metabolic indices.

      RESEARCH PLAN:

      We will conduct a randomized, placebo controlled, add on treatment trial of Sensoril® (added
      to ongoing prescribed pharmacological mood stabilizer) for a period of 8 weeks. Measures of
      cognition, psychopathology and laboratory indices will be utilized for evaluating primary and
      secondary outcomes, along with safety assessments.

      METHODS:

      Up to Seventy-six subjects with DSM IV bipolar I disorder will be recruited from Western
      Psychiatric Institute and Clinic. Using a 1:1 randomization, subjects who sign an informed
      consent document will be randomized to receive Sensoril® or placebo.

      It is expected that 16 of the 76 subjects may not meet inclusion/exclusion criteria, leaving
      60 consenting adults (18 to 65 years) with DSM IV-TR Bipolar Disorder who will be assessed
      for euthymia (Young Mania Rating Scale Score of less than or equal to 10, Montgomery Asberg
      Depression Rating Scale Score of less than or equal to 10) over the period of 4 weeks while
      receiving stable doses of their current mood stabilizer. They will also be assessed for
      cognitive dysfunction (attention/executive function, immediate and declarative memory,
      psychomotor performance) using Cogtest - a proprietary neuropsychological battery of tests.
      These subjects will be characterized for normal pre-morbid IQ, no ECT treatment in past 6
      months, no alcohol or substance dependence in past 6 months, mini-mental state score of 23 or
      more.

      Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day,
      increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if
      tolerability is an issue) will be continued fora total of 8 weeks. Sensoril® is not known to
      have interactions with psychotropic drugs, but mood-stabilizer levels will be monitored at
      the beginning and end of the study. The principal investigator has worked with a New Jersey
      based company (Natreon, Inc.) to obtain an IND from the FDA for Sensoril® treatment of
      cognitive dysfunction in persons with Bipolar disorder (IND #102616).

      Standard psychopathology rating scales will be administered to evaluate impact if any on
      residual symptoms of bipolar disorder. Laboratory indices (glucose/lipids) will be evaluated
      at baseline and end of study. Safety will be assessed through a comprehensive health
      assessment, including medical history, and evaluation of laboratory measures. Any adverse
      effects will be assessed by asking questions at each visit, and if necessary, follow up via
      telephone contact or bringing subjects in for assessments outside the scheduled visits.

      SIGNIFICANCE:

      Cognitive dysfunction can seriously hinder improved functional outcomes in persons with
      bipolar disorder. If this short term intervention with Sensoril® shows promise, more
      definitive studies using adequate powered sample sizes, and of longer duration can be
      conducted. If improvements in cognitive problems are linked to improved functional outcomes
      using such supplemental treatments, an important therapeutic milestone in bipolar disorder
      will have been achieved.
    

Intervention name(s): Sensoril; Placebo
Intervention type(s): Drug; Other
Other intervention name(s): Ashwagandha; Sugar Pill
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sensoril; Bipolar Illness; Cognitive enhancement