Schizophrenic DisorderPhase 2/3NCT03010865
Sodium Butyrate For Improving Cognitive Function In Schizophrenia
A Phase 2/3 study testing Sodium Butyrate in people with Schizophrenic Disorder and Cognitive Impairment, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
The purpose of this grant is to evaluate the efficacy of sodium butyrate as a novel treatment for cognitive deficits in schizophrenia (SZ). The aims will be to evaluate its effects on improving symptoms and functioning in SZ, and the relationship of the drug's clinical effects to epigenetic and inflammation related… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenic Disorder, Cognitive Impairment
- What is being tested?
- Sodium Butyrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to Feb 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects who have cognitive deficits as indicated by a score of < 85 on RBANS,
- meet criteria for DSM-5 diagnosis of chronic SZ, schizoaffective disorder (SA),
- Subjects who are stably treated with antipsychotic medications and are not in acute exacerbation of illness symptoms.
Who cannot join
- History of mental retardation or pervasive developmental disorder,
- Subjects with a current serious neurological/CNS disorder (such as seizure disorder, stroke or multiple sclerosis) or brain trauma,
- Current treatment with valproic acid, butyrate drugs, sulforaphane, or other drugs or chemicals known to have high HDAC inhibitory activity,
- Pregnancy,
- Severe unstable medical condition,
- Current suicidal or homicidal thoughts,
- Current alcohol or substance abuse (other than nicotine or occasional marijuana) in the last month.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
About this study
Official title: Sodium Butyrate As A Treatment For Improving Cognitive Function In Schizophrenia
The purpose of this grant is to evaluate the efficacy of sodium butyrate as a novel treatment for cognitive deficits in schizophrenia (SZ). The aims will be to evaluate its effects on improving symptoms and functioning in SZ, and the relationship of the drug's clinical effects to epigenetic and inflammation related biochemical changes.
Read the detailed description
The persistent cognitive deficits which can be appreciated across the course of SZ, from prodromal to chronic SZ, may be the most important underlying dysfunction in preventing functional, occupational, and social recovery in SZ compared to other symptom domains. Sodium butyrate is a short chain fatty acid and binds to the zinc site of histone deacetylases (HDAC). The inhibition of HDAC results in histone hyperacetylation. This study aims to evaluate its effects on improving symptoms and functioning in SZ, and the relationship of the drug's clinical effects to epigenetic and inflammation related biochemical changes.
The proposed study will be a double blind study of the effects of sodium butyrate on cognitive function and symptoms in chronic SZ patients showing continued cognitive deficits.The primary specific aims of the proposal will be to test the the MATRICS (MCCB) battery,delayed recall performance, and performance on real world functional tasks as assessed by the USCD Performance- Based Skills Assessment Battery (UPSA). In addition, we will also investigate whether sodium butyrate may improve other aspects of cognition.
We will also explore whether improvement in cognition is related to change in HDAC activity in peripheral blood cells and changes in inflammatory makers in the blood, and assess whether there is any improvement in psychopathology as measured by PANSS scale.
- Conditions
- Schizophrenic Disorder, Cognitive Impairment
- Being tested
- Sodium Butyrate, Placebo Oral Capsule
- Keywords
- HDAC inhibitors, Inflammation
- Medical subject headings
- Schizophrenia, Cognitive Dysfunction, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium ButyrateDrug
Sodium butyrate is being supplied by T.E. Neesby (Brain White, T.E. Neesby, Inc.) in 730 mg capsules. The company asserts that their material is 98% pure and food grade. We will have identical placebo capsules. Subjects will receive 3 capsules twice daily (morning and late afternoon or evening) for a total of 4380 mg/day.
Placebo Oral CapsuleDrug
Placebo Oral Capsule is also being supplied by T.E. Neesby (Brain White, T.E. Neesby, Inc.) and there is no difference from appearance, smell and taste. It contains 1.5 mg sodium butyrate per capsule. Subjects will receive 3 capsules twice daily (morning and late afternoon or evening) for a total of 9 mg/day.
| Study group | Role | What they receive |
|---|---|---|
| Sodium Butyrate | Experimental | Dietary Supplement: Sodium Butyrate 4.38 gms of sodium butyrate per day for 12 weeks Receives: Drug: Sodium Butyrate |
| Placebo Oral Capsule | Placebo comparator | Placebo Oral Capsule placebo capsules containing approximately 9 mg of sodium butyrate per day Receives: Drug: Placebo Oral Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in MATRICS Battery Score
MATRICS Cognitive Battery
Measured: Basline, week 6, up to 12 weeks
Secondary outcomes (4)
Change from baseline in Logical Memory Test score
Logical Memory Test for longer term memory
Measured: Basline, up to 12 weeks
Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score
Positive and Negative Syndrome Scale (PANSS) symptom rating scale
Measured: Basline, week 6, up to 12 weeks
Change from baseline in Paced Auditory Serial Addition Test (PASAT) score
Alternate working memory test
Measured: Basline, week 6, up to 12 weeks
Change from baseline in UCSD Performance-Based Skills Assessment (UPSA) total score
University of California, San Diego (UCSD) Performance-Based Skills Assessment Battery
Measured: Baseline, up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study start1 Jun 2017
- Primary completionDec 2019 (estimated)
- Study completionFeb 2020 (estimated)
Why it stopped: sponsor withdrew the funds because the smell of sodium butyrate made blinding impossible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenic DisorderStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Stanley Medical Research Institute
- Responsible party
- Sponsor
- Investigators
- Chunbo Li, M.D., Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010865
- Sponsor's protocol ID
- 2016-12
- Status last verified
- Jun 2017
- First submitted
- 28 Dec 2016
- Last updated
- 17 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Stanley foundation requests: Based on the terms of your award, Stanley Medical Research Institute (SMRI) now requires submission of the individual patient data from all SMRI funded studies. In order to make the process as efficient as possible and provide a secure location for study data, National Institute of Mental Health (NIMH) is graciously allowing SMRI access to their National Database for Clinical Trials (NDCT) to collect and house data.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium Butyrate As A Treatment For Improving Cognitive Function In Schizophrenia
- ClinicalTrials.gov ID
- NCT03010865
- Acronym / sponsor ID
- 2016-12
- Conditions
- Schizophrenic Disorder, Cognitive Impairment
- Keywords
- HDAC inhibitors, Inflammation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: sponsor withdrew the funds because the smell of sodium butyrate made blinding impossible
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Stanley Medical Research Institute
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 5 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this grant is to evaluate the efficacy of sodium butyrate as a novel treatment for cognitive deficits in schizophrenia (SZ). The aims will be to evaluate its effects on improving symptoms and functioning in SZ, and the relationship of the drug's clinical effects to epigenetic and inflammation related biochemical changes.
Detailed description
The persistent cognitive deficits which can be appreciated across the course of SZ, from prodromal to chronic SZ, may be the most important underlying dysfunction in preventing functional, occupational, and social recovery in SZ compared to other symptom domains. Sodium butyrate is a short chain fatty acid and binds to the zinc site of histone deacetylases (HDAC). The inhibition of HDAC results in histone hyperacetylation. This study aims to evaluate its effects on improving symptoms and functioning in SZ, and the relationship of the drug's clinical effects to epigenetic and inflammation related biochemical changes.
The proposed study will be a double blind study of the effects of sodium butyrate on cognitive function and symptoms in chronic SZ patients showing continued cognitive deficits.The primary specific aims of the proposal will be to test the the MATRICS (MCCB) battery,delayed recall performance, and performance on real world functional tasks as assessed by the USCD Performance- Based Skills Assessment Battery (UPSA). In addition, we will also investigate whether sodium butyrate may improve other aspects of cognition.
We will also explore whether improvement in cognition is related to change in HDAC activity in peripheral blood cells and changes in inflammatory makers in the blood, and assess whether there is any improvement in psychopathology as measured by PANSS scale.
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 |
|---|---|---|
| Sodium Butyrate | Experimental | Drug: Sodium ButyrateDietary Supplement: Sodium Butyrate 4.38 gms of sodium butyrate per day for 12 weeks |
| Placebo Oral Capsule | Placebo comparator | Drug: Placebo Oral CapsulePlacebo Oral Capsule placebo capsules containing approximately 9 mg of sodium butyrate per day |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects who have cognitive deficits as indicated by a score of < 85 on RBANS,
- meet criteria for DSM-5 diagnosis of chronic SZ, schizoaffective disorder (SA),
- Subjects who are stably treated with antipsychotic medications and are not in acute exacerbation of illness symptoms.
Key exclusion criteria (7 listed)
- History of mental retardation or pervasive developmental disorder,
- Subjects with a current serious neurological/CNS disorder (such as seizure disorder, stroke or multiple sclerosis) or brain trauma,
- Current treatment with valproic acid, butyrate drugs, sulforaphane, or other drugs or chemicals known to have high HDAC inhibitory activity,
- Pregnancy,
- Severe unstable medical condition,
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 |
|---|---|---|
| Sodium ButyrateSodium butyrate is being supplied by T.E. Neesby (Brain White, T.E. Neesby, Inc.) in 730 mg capsules. The company asserts that their material is 98% pure and food grade. We will have identical placebo capsules. Subjects will receive 3 capsules twice daily (morning and late afternoon or evening) for a total of 4380 mg/day. | Drug | Sodium Butyrate |
| Placebo Oral CapsulePlacebo Oral Capsule is also being supplied by T.E. Neesby (Brain White, T.E. Neesby, Inc.) and there is no difference from appearance, smell and taste. It contains 1.5 mg sodium butyrate per capsule. Subjects will receive 3 capsules twice daily (morning and late afternoon or evening) for a total of 9 mg/day. | Drug | Placebo Oral Capsule |
Primary outcome
Change from baseline in MATRICS Battery Score
Time frame: Basline, week 6, up to 12 weeks
MATRICS Cognitive Battery
4 secondary outcomes
Change from baseline in Logical Memory Test score
Time frame: Basline, up to 12 weeks
Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score
Time frame: Basline, week 6, up to 12 weeks
Change from baseline in Paced Auditory Serial Addition Test (PASAT) score
Time frame: Basline, week 6, up to 12 weeks
Change from baseline in UCSD Performance-Based Skills Assessment (UPSA) total score
Time frame: Baseline, up to 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2019.
- Individual participant dataSharing planned: Undecided. Stanley foundation requests: Based on the terms of your award, Stanley Medical Research Institute (SMRI) now requires submission of the individual patient data from all SMRI funded studies. In order to make the process as efficient as possible and provide a secure location for study data, National Institute of Mental Health (NIMH) is graciously allowing SMRI access to their National Database for Clinical Trials (NDCT) to collect and house data.
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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.
Chunbo Li, M.D. principal investigator
Shanghai Mental Health Center
1 site 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 Sodium Butyrate in people with Schizophrenic Disorder and Cognitive Impairment, run by Shanghai Mental Health Center at 1 site in China.
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 3 inclusion and 7 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: withdrawn, as of the sponsor's last update on 17 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change from baseline in MATRICS Battery Score (time frame: Basline, week 6, up to 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 17 Jan 2019.