Sensoril(Ashwaganhda)for Bipolar Disorder

Completed · Phase 3 · Has a placebo group

Conditions studied: Bipolar I Disorder, Bipolar II Disorder, Bipolar Disorder NOS

In brief

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.

Key facts

Study ID

NCT00761761

Run by

University of Pittsburgh

People needed

60

Starts

2008-10-01

Expected to finish

2011-03-01

Last updated by the study team

2016-04-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• DSMIV-TR diagnosis of Bipolar Disorder
• Ages 18 to 65
• Men or Women
• 8th grade education or greater
• Able to provide competent written informed consent
• Current main mood stabilizer and mood status (YMRS and MADRS scores less than or equal to 10) are stable for greater than or equal to 4 weeks by history.

You may not qualify if…

• Medically unstable conditions
• Known allergy to Sensoril® (or Ashwagandha)
• Current cognitive decline is attributable to a diagnosis of dementia or other neurological disorder
• Pregnant or lactating women
• Mini-mental score (MMSE) less than or equal to 23
• Currently receiving donepezil, rivastigamine, or galatamine, or memantine or any marketed agent for slowing memory loss in dementia
• Abnormal clinical thyroid status
• Currently (or within past 2 weeks) receiving St. John's Wort, Gingko or Omega-3

Where it is running

• Western Psychiatric Institute and Clinic University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Western Psychiatric Institute and Clinic — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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