NCT00403247

Brief Summary

The purpose of this study is to determine whether individuals with schizophrenia who will take a high dose of the B-vitamins folate, B12 and pyridoxine, may experience improvement in their symptoms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Jul 2004

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 23, 2006

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

August 23, 2007

Status Verified

August 1, 2007

First QC Date

November 22, 2006

Last Update Submit

August 21, 2007

Conditions

SchizophreniaSchizoaffective Disorder

Keywords

SchizophreniaSchizoaffective DisorderHomocysteineVitamins

Outcome Measures

Primary Outcomes (1)

  • blood homocysteine levels

    12 weeks after baseline

Secondary Outcomes (6)

  • CGI (Clinical Global Improvement)

    12 weeks after baseline

  • CDSS (Calgary Depression Scale for Schizophrenia)

    12 weeks after baseline

  • WAIS-II Memory Scale (Immediate and Delayed)

    12 weeks after baseline

  • WAIS Digit Symbol-Coding

    12 weeks after baseline

  • Wisconsin Card Sorting Test

    12 weeks after baseline

  • +1 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL

vitamin capsule

Dietary Supplement: Capsule with folate, Vitamin B12 & pyridoxine

B

PLACEBO COMPARATOR

placebo capsule

Other: placebo

Interventions

Capsule with folate, Vitamin B12 & pyridoxineDIETARY_SUPPLEMENT
A
placeboOTHER

placebo capsule

B

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Schizophrenia or Schizoaffective Disorder
  • Ages 18-65, male or female
  • Treatment regimen includes a new-generation antipsychotic (clozapine, olanzapine,risperidone, quetiapine, ziprasidone or aripiprazole)
  • Stable medication for 4 weeks prior to screening visit

You may not qualify if:

  • Diagnosis of active substance use disorder within the last month
  • Already taking vitamin supplements totaling \> 400 mcg folic acid per day, or regular B12 injections
  • Pregnant or breastfeeding
  • Seizure disorder
  • Non-English speaking
  • Without capacity to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Nathan Kline Institute for Psychiatric Research

Orangeburg, New York, 10962, United States

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Vitamin B 12Pyridoxine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CorrinoidsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic CompoundsVitamin B 6PicolinesPyridines

Study Officials

  • William M Greenberg, M.D.

    The Nathan Kline Institute for Psychiatric Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 22, 2006

First Posted

November 23, 2006

Study Start

July 1, 2004

Study Completion

July 1, 2007

Last Updated

August 23, 2007

Record last verified: 2007-08

Locations

US(1)