TerminatedNCT03437668Updated Oct 8, 2024Results posted

Adjunctive Withania Somnifera (Ashwagandha) for Persistent Symptoms in People With Schizophrenia

A Phase 2/3 interventional study of WSE and Placebo Oral Tablet in Schizophrenia, sponsored by Chengappa, K.N. Roy, MD. Terminated at 2 sites in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2024-10-08.

Sponsored by Chengappa, K.N. Roy, MD · Phase 2/3, Interventional, and Treatment

Why this study was terminated

Unable to reach enrollment target due to COVID

Phase: Phase 2/3
Study type: Interventional
Enrollment: 47
Allocation: Randomized
Ages: 18 Years to 64 Years
Sex: All

Study summary

To determine whether a standardized extract of Withania somnifera will reduce psychopathology scores (PANSS total score) in persons with schizophrenia. A secondary aim is to determine whether WSE reduces measures of positive and negative symptoms (PANSS subscales) and stress scores on the Perceived Stress Scale (PSS).

Conditions studied

Schizophrenia

Browse trials for

Schizophrenia 3,464

Keywords

Schizophrenia
Withania Somnifera

Who can participate

Ages eligible: 18 Years to 64 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Diagnostic and Statistical Manual (DSM) 5 diagnosis of schizophrenia or schizoaffective disorder
Ability to provide informed written consent
PANSS total score ≥ 70 or a CGI Severity Scored ≥ 4; and at least 2 positive symptom subscale items (i.e., delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility and unusual thought content) scoring ≥ 4, or one of these items scoring ≥ 5, on a scale ranging from 1 = absent to 7 = extreme.
Evidence of a positive symptom exacerbation during the year prior to study entry.
For women of child bearing age, a negative serum pregnancy test at screening

Exclusion criteria

Exclusion Criteria:

Testing positive for illicit substances (positivity to marijuana or opioids will be assessed on a case by case basis due to the long elimination half life in the urine of marijuana and the use of opioids for various pain disorders, caffeine and nicotine are excepted)
Receiving pharmacological treatment for addictions (naltrexone, suboxone, acamprosate, others) will be reviewed on a case by case basis
Seriously unstable medical illnesses
Pregnant or breast feeding women
Known allergy or history of serious adverse event with WSE
Subjects who may require imminent hospitalization (examples: suicidal or aggressive behavior)
Currently receiving antibiotics, anti-viral, or anti-parasitic medications
Currently receiving immunosuppressive medications (e.g. oral scheduled corticosteroids, chemotherapy or transplantation or HIV/AIDS associated drugs).

Study design

Phase: Phase 2 / Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 47 participants (actual)

Study arms

Experimental
Withania Somnifera Extract (WSE)
WSE 500 mg bid for 12 weeks
Drug: WSE
Placebo comparator
Placebo tablets
Placebo oral tablet bid for 12 weeks
Drug: Placebo Oral Tablet

Interventions

DrugWSE
WSE tablets
Also known as: Withania somnifera extracts, Ashwagandha, Sensoril®
DrugPlacebo Oral Tablet
Placebo tablet

What researchers measure

Primary outcomes

Positive and Negative Symptom Scale
The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of patients with schizophrenia. To assess a patient using PANSS, an approximately 45-minute clinical interview is conducted. The patient is rated from 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. Subjects can not score lower than 30 or higher than 210. Higher score indicates higher amount of psychopathology
Time frame: 12 weeks

Secondary outcomes

PANSS Negative Factor Score Also Know as Marder Factors
The Marder negative factor is a factor-analysis derived dimension of the Positive and Negative Syndrome Scale (PANSS) that measures negative symptoms of schizophrenia. It's made up of seven items from the PANSS, including: Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic withdrawal, Motor retardation, Active social avoidance, Lack of spontaneity in conversation. Each item is scored from 1 to 7 with a higher score indicating greater severity. Minimum score is 7 and maximum is 49
Time frame: 12 weeks

Results

Posted Oct 8, 2024

Participant flow

Participant flow — Overall Study
Milestone	Withania Somnifera Extract (WSE)	Placebo Tablets
Started	24	23
Completed	20	19
Not completed	4	4

Outcome measures

PrimaryPositive and Negative Symptom Scale

The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of patients with schizophrenia. To assess a patient using PANSS, an approximately 45-minute clinical interview is conducted. The patient is rated from 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. Subjects can not score lower than 30 or higher than 210. Higher score indicates higher amount of psychopathology

Time frame:: 12 weeks
Reported as:: Least squares mean · score on a scale

Positive and Negative Symptom Scale
score on a scale	Withania Somnifera Extract (WSE)	Placebo Tablets
Week 0	65.0 ± 2.6	75.1 ± 2.6
Week 6	63.2 ± 2.4	72.0 ± 2.5
Week 12	61.3 ± 2.7	68.8 ± 2.7

Statistical analysis

Withania Somnifera Extract (WSE) vs Placebo Tablets · Mixed Models Analysis · p = .31 (p-value is for the interaction of time and treatment group in the mixed model) · Slope: -0.22

SecondaryPANSS Negative Factor Score Also Know as Marder Factors

The Marder negative factor is a factor-analysis derived dimension of the Positive and Negative Syndrome Scale (PANSS) that measures negative symptoms of schizophrenia. It's made up of seven items from the PANSS, including: Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic withdrawal, Motor retardation, Active social avoidance, Lack of spontaneity in conversation. Each item is scored from 1 to 7 with a higher score indicating greater severity. Minimum score is 7 and maximum is 49

Time frame:: 12 weeks
Reported as:: Least squares mean · score on a scale

PANSS Negative Factor Score Also Know as Marder Factors
score on a scale	Withania Somnifera Extract (WSE)	Placebo Tablets
Baseline	2.05 ± .84	2.68 ± .67
12 weeks	2.10 ± .80	2.45 ± .69

Adverse events

Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Withania Somnifera Extract (WSE)	0/24 (0%)	1/24 (4.2%)	12/24 (50%)
Placebo Tablets	0/23 (0%)	3/23 (13%)	18/23 (78.3%)

Most frequent serious events

Most frequent serious events
Event	Withania Somnifera Extract (WSE)	Placebo Tablets
Suicidal ideationPsychiatric disorders	1/24	2/23
COVID 19Infections and infestations	0/24	1/23

Most frequent other events

Showing 10 of 20

Most frequent other events
Event	Withania Somnifera Extract (WSE)	Placebo Tablets
Objective tinnitusEar and labyrinth disorders	0/24	2/23
ConstipationGastrointestinal disorders	2/24	1/23
NauseaGastrointestinal disorders	2/24	1/23
Abdominal painGastrointestinal disorders	1/24	1/23
DiarrheaGastrointestinal disorders	0/24	1/23
Dry MouthGastrointestinal disorders	1/24	1/23
Nausea and vomitingGastrointestinal disorders	1/24	1/23
FatigueGeneral disorders	0/24	1/23
EndometritisInfections and infestations	0/24	1/23
Upper Respiratory InfectionInfections and infestations	0/24	1/23

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Withania Somnifera Extract (WSE)	Placebo Tablets	Total
Mean	43.7 ± 10.9	43.8 ± 12.1	43.7 ± 11.4

Sex: Female, Male
Sex: Female, Male(Participants)	Withania Somnifera Extract (WSE)	Placebo Tablets	Total
Female	6	3	9
Male	18	20	38

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Withania Somnifera Extract (WSE)	Placebo Tablets	Total
Hispanic or Latino	1	2	3
Not Hispanic or Latino	22	21	43
Unknown or Not Reported	1	0	1

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Withania Somnifera Extract (WSE)	Placebo Tablets	Total
American Indian or Alaska Native	0	0	0
Asian	1	1	2
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	5	9	14
White	16	12	28
More than one race	2	1	3
Unknown or Not Reported	0	0	0

Study locations

2 sites

UCLA
Los Angeles, California 90095, United States
Maryland Psychiatric Research Center
Catonsville, Maryland 21228, United States

References and documents

Study documents

Protocol and statistical analysis plan · Feb 13, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided — Deidentified will be submitted an NIH repository

Registry details

Key details

Study ID: NCT03437668
Lead sponsor: Chengappa, K.N. Roy, MD
Collaborators: Stanley Medical Research Institute, University of Maryland
Responsible party: Stephen Marder (Professor, University of California, Los Angeles) — Principal investigator
First posted: Feb 19, 2018
Start date: Dec 1, 2018
Primary completion: Jun 12, 2023
Completion: Jun 12, 2023
Results posted: Oct 8, 2024
Last update: Oct 8, 2024

Study contacts

Stephen Marder, MD

study chair · Semel Inst at UCLA

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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