Sensoril(Ashwaganhda)for Bipolar Disorder

NCT00761761 | Completed Phase 3 Results DMC

• 2 other identifiers: Chengappa SensorilUniv.Pitts IRB# PRO08060267
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Bipolar I Disorder; Bipolar II Disorder; Bipolar Disorder NOS

Keywords

Sensoril; Bipolar Illness; Cognitive enhancement

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Digit-Span Score at 8 Weeks

  Cognition was assessed using tests developed by The Cognition Group-(TCG); London, UK; and Delaware, USA. Testing procedures and consistency was assured by the same staff-patient dyad, and a TCG staff person had previously trained the research staff (Chengappa et al, 2012). A comprehensive cognitive battery was assessed. Details of these cognitive tests are available at http://www.cogtest.com, and are also described in other studies (Harvey et al, 2007, Lindenmayer et al, 2011, Chengappa et al, 2012). However, the results for Digit span which assesses short term or working memory are presented. The raw scores for "digit span" ranges from a minimum of 2 to a maximum of 8. The Digit Span test measures working memory and the longer the span the better the cognition therefore the higher score is the better outcome.

  8 week treatment

Secondary Outcomes (3)

• Sensoril® Treatment Will Secondarily Improve Any Residual Depressive Symptoms

  Baseline and 8 week treatment

• Sensoril Treatment Will Secondarily Improve Any Residual Symptoms of Mania.

  Baseline and 8 weeks treatment

• Sensoril Treatment Will Secondarily Improve Any Residual Anxiety Symptoms

  Baseline and 8 week treatment

Study Arms (2)

1- Sensoril (Ashwagandha)

EXPERIMENTAL

Sensoril (Ashwagandha) will be administered using random assignment at a dose of 250 mg/day, increasing to a dose of 500 mg/day by the second week.

Drug: Sensoril

2 - Placebo

PLACEBO COMPARATOR

Placebo will be administered using random assignment at a dose of 250 mg/day, increasing to a dose of 500 mg/day by the second week.

Other: Placebo

Interventions

Sensoril DRUG

Also known as: Ashwagandha

1- Sensoril (Ashwagandha)

Placebo OTHER

Also known as: Sugar Pill

2 - Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DSMIV-TR diagnosis of Bipolar Disorder
• Ages 18 to 65
• Men or Women
• th 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Alliance for Research on Schizophrenia and Depression: collaborator

Study Sites (2)

Western Psychiatric Institute and Clinic University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213-2593, United States

Location

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Chengappa KN, Bowie CR, Schlicht PJ, Fleet D, Brar JS, Jindal R. Randomized placebo-controlled adjunctive study of an extract of withania somnifera for cognitive dysfunction in bipolar disorder. J Clin Psychiatry. 2013 Nov;74(11):1076-83. doi: 10.4088/JCP.13m08413.

  PMID: 24330893 DERIVED

Related Links

• Connect to NARSAD list of active research studies

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Ashwagandha; Sugars

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbohydrates

Results Point of Contact

• Title: K.N. Roy Chengappa, MD
• Organization: Univeristy Of Pittsburgh Medical Center

chengappakn@upmc.edu

412-246-5006

Study Officials

• K. N. Roy Chengappa, MD

  Western Psychiatric Institute and Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: September 25, 2008
• First Posted: September 29, 2008
• Study Start: October 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: April 14, 2016
• Results First Posted: April 14, 2016

Record last verified: 2016-03

Locations

US (2)