SchizophreniaNCT02916121
Potential Intervention Strategy With Folic Acid and Vitamin B12 in Patients With Schizophrenia
A study testing folic acid 5 mg/cap in people with Schizophrenia, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
The investigators study aims are: 1. To investigate folate, vitamin B12, and homocysteine levels in patients with schizophrenia. 2. To evaluate the relationships among folate, vitamin B12, and homocysteine levels, genetic variants of one-carbon cycle pathway, psychopathology, including positive symptoms, negative… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- folic acid 5 mg/cap
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2016to Dec 2018
- Phase
- Interventional
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20-65 year-old.
- Fulfill DSM-IV-TR diagnosis of schizophrenia.
- Be treated with an antipsychotic agent for at least 6 months or at a stable dose for at least 3 months.
- Patients with folate deficiency or insufficiency, and PANSS score at least 60 or more in the first phase screening.
- Folate deficiency and insufficiency (low folate level) are defined as serum folate < 6.8 nmol/L (3 ng/mL) and <= 13.5 nmol/L (6 ng/mL), respectively.
Who cannot join
- Medically unstable.
- Currently taking vitamin supplementation.
- Pregnancy or lactation.
- Test positive of urine drug screen
- Megaloblastic anemia due to folate deficiency;
- Patients with parkinsonism (score of > 12 on the Simpson-Angus Scale);
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- History of alcohol or other substances use disorder in past 3 months;
- History of significant neurological illness;
- Creatine>1.4 ng/dl.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationships of One-carbon Cycle Pathway With Psychopathology and Metabolic Abnormalities in Patients With Schizophrenia and Potential Intervention Strategy With Folic Acid and Vitamin B12
The investigators study aims are:
- To investigate folate, vitamin B12, and homocysteine levels in patients with schizophrenia.
- To evaluate the relationships among folate, vitamin B12, and homocysteine levels, genetic variants of one-carbon cycle pathway, psychopathology, including positive symptoms, negative symptoms, and cognition, and metabolic abnormalities in patients with schizophrenia.
- For patients with low folate levels, the investigators would like to conduct a 24-week double-blinded, placebo-controlled of folic acid (5 mg/d) and vitamin B12 (500 ug/d) supplementation study to know whether combination of folic acid and vitamin B12 can improve patients' psychopathology or metabolic profiles, and the effects of genetic variants in one-carbon cycle pathway on treatment response.
- Conditions
- Schizophrenia
- Being tested
- folic acid 5 mg/cap, Placebo
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
folic acid 5 mg/capDietary supplement
Also called vitamine B12 500 ug/cap
the intervention includes folic acid 5 mg/d and vitamin B12 500 ug/d
PlaceboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| folic acid 5 mg/cap | Experimental | folic acid 5 mg/d and vitamin B12 500 ug/d Receives: Dietary Supplement: folic acid 5 mg/cap |
| placebo | Placebo comparator | placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Syndrome Scale (PANSS)
We used PANSS to evaluate patients' psychopathology at baseline, week-2, 4, 8, 12, 16, 20, and 24.
Measured: 24 weeks
Secondary outcomes (6)
CogStat neuropsychological test, including speed of processing, attention, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition
CogStat will be used to test patients' cognitive function, including speed of processing, attention, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition, at baseline and week-24.
Measured: 24 weeks
blood pressure, mmHg
Blood pressure will be checked at week 4, 12, and 24.
Measured: 24 weeks
waist circumference, cm
Waist circumference will be checked at week 4, 12, and 24.
Measured: 24 weeks
triglyceride, mg/dL
Triglyceride will be checked at week 4, 12, and 24.
Measured: 24 weeks
high density lipoprotein cholesterol (HDL-C), mg/dL
HDL-C will be checked at week 4, 12, and 24.
Measured: 24 weeks
fasting blood sugar level, mg/dL
fasting blood sugar level will be checked at week 4, 12, and 24.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionAug 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun-Hsin Chen, MD, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916121
- Sponsor's protocol ID
- 201408009
- Status last verified
- Aug 2016
- First submitted
- 29 Aug 2016
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationships of One-carbon Cycle Pathway With Psychopathology and Metabolic Abnormalities in Patients With Schizophrenia and Potential Intervention Strategy With Folic Acid and Vitamin B12
- ClinicalTrials.gov ID
- NCT02916121
- Acronym / sponsor ID
- 201408009
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 27 Sep 2016 (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 investigators study aims are:
- To investigate folate, vitamin B12, and homocysteine levels in patients with schizophrenia.
- To evaluate the relationships among folate, vitamin B12, and homocysteine levels, genetic variants of one-carbon cycle pathway, psychopathology, including positive symptoms, negative symptoms, and cognition, and metabolic abnormalities in patients with schizophrenia.
- For patients with low folate levels, the investigators would like to conduct a 24-week double-blinded, placebo-controlled of folic acid (5 mg/d) and vitamin B12 (500 ug/d) supplementation study to know whether combination of folic acid and vitamin B12 can improve patients' psychopathology or metabolic profiles, and the effects of genetic variants in one-carbon cycle pathway on treatment response.
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 |
|---|---|---|
| folic acid 5 mg/cap | Experimental | Dietary Supplement: folic acid 5 mg/capfolic acid 5 mg/d and vitamin B12 500 ug/d |
| placebo | Placebo comparator | Other: Placeboplacebo |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 20-65 year-old.
- Fulfill DSM-IV-TR diagnosis of schizophrenia.
- Be treated with an antipsychotic agent for at least 6 months or at a stable dose for at least 3 months.
- Patients with folate deficiency or insufficiency, and PANSS score at least 60 or more in the first phase screening.
- Folate deficiency and insufficiency (low folate level) are defined as serum folate < 6.8 nmol/L (3 ng/mL) and <= 13.5 nmol/L (6 ng/mL), respectively.
Key exclusion criteria (9 listed)
- Medically unstable.
- Currently taking vitamin supplementation.
- Pregnancy or lactation.
- Test positive of urine drug screen
- Megaloblastic anemia due to folate deficiency;
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 |
|---|---|---|
| folic acid 5 mg/capAlso: vitamine B12 500 ug/capthe intervention includes folic acid 5 mg/d and vitamin B12 500 ug/d | Dietary supplement | folic acid 5 mg/cap |
| Placeboplacebo | Other | placebo |
Primary outcome
Positive and Negative Syndrome Scale (PANSS)
Time frame: 24 weeks
We used PANSS to evaluate patients' psychopathology at baseline, week-2, 4, 8, 12, 16, 20, and 24.
6 secondary outcomes
CogStat neuropsychological test, including speed of processing, attention, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition
Time frame: 24 weeks
blood pressure, mmHg
Time frame: 24 weeks
waist circumference, cm
Time frame: 24 weeks
triglyceride, mg/dL
Time frame: 24 weeks
high density lipoprotein cholesterol (HDL-C), mg/dL
Time frame: 24 weeks
fasting blood sugar level, mg/dL
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2016.
- Individual participant dataSharing planned: Undecided
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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.
Chun-Hsin Chen, MD principal investigator
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing folic acid 5 mg/cap in people with Schizophrenia, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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 9 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: status not confirmed, as of the sponsor's last update on 27 Sep 2016. 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 Taiwan. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chun-Hsin Chen, MD (886-970-746395, chunhsin57@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative Syndrome Scale (PANSS) (time frame: 24 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 27 Sep 2016.