NCT02916121

Brief Summary

The investigators study aims are:

  1. 1.To investigate folate, vitamin B12, and homocysteine levels in patients with schizophrenia.
  2. 2.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.
  3. 3.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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2016

Completed
29 days until next milestone

First Posted

Study publicly available on registry

September 27, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

September 27, 2016

Status Verified

August 1, 2016

Enrollment Period

1.8 years

First QC Date

August 29, 2016

Last Update Submit

September 22, 2016

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Positive and Negative Syndrome Scale (PANSS)

    We used PANSS to evaluate patients' psychopathology at baseline, week-2, 4, 8, 12, 16, 20, and 24.

    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

    24 weeks

  • blood pressure, mmHg

    24 weeks

  • waist circumference, cm

    24 weeks

  • triglyceride, mg/dL

    24 weeks

  • high density lipoprotein cholesterol (HDL-C), mg/dL

    24 weeks

  • +1 more secondary outcomes

Study Arms (2)

folic acid 5 mg/cap

EXPERIMENTAL

folic acid 5 mg/d and vitamin B12 500 ug/d

Dietary Supplement: folic acid 5 mg/cap

placebo

PLACEBO COMPARATOR

placebo

Other: Placebo

Interventions

folic acid 5 mg/capDIETARY_SUPPLEMENT

the intervention includes folic acid 5 mg/d and vitamin B12 500 ug/d

Also known as: vitamine B12 500 ug/cap
folic acid 5 mg/cap
PlaceboOTHER

placebo

placebo

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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);
  • History of alcohol or other substances use disorder in past 3 months;
  • History of significant neurological illness;
  • Creatine\>1.4 ng/dl.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University - WanFang Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Folic AcidCapsules

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDosage FormsPharmaceutical Preparations

Study Officials

  • Chun-Hsin Chen, MD

    Taipei Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun-Hsin Chen, MD

CONTACT

886-970-746395chunhsin57@yahoo.com.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2016

First Posted

September 27, 2016

Study Start

October 1, 2016

Primary Completion

August 1, 2018

Study Completion

December 1, 2018

Last Updated

September 27, 2016

Record last verified: 2016-08

Locations

TW(1)