SchizophreniaPhase 2/3NCT03437668
Adjunctive Withania Somnifera (Ashwagandha) for Persistent Symptoms in People With Schizophrenia
A Phase 2/3 study testing WSE in people with Schizophrenia, run by Chengappa, K.N. Roy, MD at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- WSE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Dec 2018to 12 Jun 2023
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Maryland Psychiatric Research Center
Catonsville, Maryland, 21228
UCLA
Los Angeles, California, 90095
About this study
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
- Schizophrenia
- Being tested
- WSE, Placebo Oral Tablet
- Keywords
- Schizophrenia, Withania Somnifera
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WSEDrug
Also called Withania somnifera extracts, Ashwagandha, Sensoril®
WSE tablets
Placebo Oral TabletDrug
Placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Withania Somnifera Extract (WSE) | Experimental | WSE 500 mg bid for 12 weeks Receives: Drug: WSE |
| Placebo tablets | Placebo comparator | Placebo oral tablet bid for 12 weeks Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (1)
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start1 Dec 2018
- Primary completion12 Jun 2023
- Study completion12 Jun 2023
Why it stopped: Unable to reach enrollment target due to COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengappa, K.N. Roy, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Stanley Medical Research Institute, University of Maryland
- Responsible party
- Principal investigator, Stephen Marder, University of California, Los Angeles
- Investigators
- Stephen Marder, MD, Study chair, Semel Inst at UCLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03437668
- Sponsor's protocol ID
- PRO18030276
- Status last verified
- Sep 2024
- First submitted
- 1 Feb 2018
- Last updated
- 8 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Deidentified will be submitted an NIH repository
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Withania Somnifera (Ashwagandha) for Persistent Symptoms in People With Schizophrenia
- ClinicalTrials.gov ID
- NCT03437668
- Acronym / sponsor ID
- PRO18030276
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Withania Somnifera
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to reach enrollment target due to COVID
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Chengappa, K.N. Roy, MDUniversity, hospital or other
- Collaborators
- Stanley Medical Research Institute, University of Maryland
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 12 Jun 2023 (actual)
- Study completion
- 12 Jun 2023 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Posted 8 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Withania Somnifera Extract (WSE) | Experimental | Drug: WSEWSE 500 mg bid for 12 weeks |
| Placebo tablets | Placebo comparator | Drug: Placebo Oral TabletPlacebo oral tablet bid for 12 weeks |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WSEAlso: Withania somnifera extracts, Ashwagandha, Sensoril®WSE tablets | Drug | Withania Somnifera Extract (WSE) |
| Placebo Oral TabletPlacebo tablet | Drug | Placebo tablets |
Primary outcome
Positive and Negative Symptom Scale
Time frame: 12 weeks
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
1 secondary outcome
PANSS Negative Factor Score Also Know as Marder Factors
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. Deidentified will be submitted an NIH repository
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Marder, MD study chair
Semel Inst at UCLA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing WSE in people with Schizophrenia, run by Chengappa, K.N. Roy, MD at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative Symptom Scale (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.