Withania Somnifera: an Immunomodulator and Anti-inflammatory Agent for Schizophrenia

• Status: Completed
• Trial end date: 2016-07-07
• Target enrollment: 0
• Participant gender: All

Summary

Withania somnifera (WSE; Ashwagandha in Ayurveda) extracts have been used as an adaptogen or to build resistance to stress or diseases in indigenous medical systems in India for centuries. Modern scientific data for WSE indicate several bioactive molecules (withanolides, withanosides, indosides, withaferin-A, others) with significant immunomodulatory, anti-inflammatory and stress reducing properties.

This study will examine whether a standardized extract of Withania Somnifera (WSE; Sensoril®) will improve total, positive, negative symptoms, and stress in patients with schizophrenia. The study will examine whether WSE reduces PANSS positive and negative symptoms and stress scores in subjects, and whether these improvements are mediated by changes in inflammatory immune indices. An additional aim will determine if patients receiving WSE will have fewer adjustments to their psychotropic medications that those assigned to placebo. The study will examine whether WSE will re-balance Th1/Th2 ratios (cytokine measures) and mediate a reduction of elevated hs-CRP levels. It is hypothesized that those subjects whose Th1/Th2 ratios normalize will likely have a greater magnitude of clinical improvement versus those subjects whose immune ratios remain unbalanced.

The proposal is a 12-week, double-blind, placebo-controlled RCT of WSE added to antipsychotic medications in approximately 60 or more patients with schizophrenia with an exacerbation of symptoms. If efficacy is affirmed, this low cost extract could be studied further, and used quite readily across low, middle and high income countries.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: K.N. Roy Chengappa; University of Pittsburgh
• Treatments: Adjuvants, Immunologic; Anti-Inflammatory Agents; Immunologic Factors

Criteria

Inclusion Criteria:

1. Adult males or females (≥ 18 years, to 75 years)

2. DSM IV TR diagnosis of schizophrenia or schizoaffective disorder (If officially instituted by study initiation: DSM V diagnoses will be used).

3. Ability to provide informed written consent

4. PANSS total score ≥ 60, positive symptom cluster, (delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility and unusual thought content with at least 2 items scoring ≥ 4, or one of these items scoring ≥ 5, on a scale ranging from 1 = absent to 7 = extreme

5. Current symptom exacerbation ≥ 2 weeks, but ≤ 1 year

6. Receiving anti-psychotic medications for ≥ 4 weeks

7. For women of child bearing age, a negative pregnancy test at screening.

Exclusion Criteria:

1. Testing positive for illicit substances (marijuana or alcohol use will be assessed on a case by case basis, caffeine and nicotine are excepted)

2. Receiving pharmacological treatment for addictions (naltrexone, suboxone, acamprosate, others) will be reviewed on a case by case basis

3. Seriously unstable medical illnesses

4. Pregnant or breast feeding women

5. Known allergy or history of serious adverse event with WSE

6. Subjects who may require imminent hospitalization (examples: suicidal or aggressive behavior)

7. Currently receiving antibiotics, anti-viral, or anti-parasitic medications

8. Currently receiving immunosuppressive medications (e.g. corticosteroids, chemotherapy or transplantation or HIV/AIDs associated drugs).

9. Currently receiving NSAIDs or Aspirin (>81 mg/day) on a daily basis or PRN use > 2x/week (in the last 4 weeks).