SchizophreniaNCT00403247
Effect of High-Dose B-Complex Vitamins on the Symptoms of Schizophrenia
A study testing Capsule with folate, Vitamin B12 & pyridoxine in people with Schizophrenia and Schizoaffective Disorder, run by Nathan Kline Institute for Psychiatric Research at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Capsule with folate, Vitamin B12 & pyridoxine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Jul 2007
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Nathan Kline Institute for Psychiatric Research
Orangeburg, New York, 10962
About this study
Official title: Double-Blind Vitamin Intervention to Lower Blood Homocysteine Levels: Amino Acid and Clinical Responses in Individuals With Schizophrenia.
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.
Read the detailed description
Individuals with schizophrenia often experience disturbing residual symptoms, even with the best available current treatments. Homocysteine, normally found in the body, can interfere with NMDA-glutamate receptor function, and this might be responsible for some of the symptoms of schizophrenia. This double-blind protocol will have study participants who suffer from schizophrenia take either a high-dose combination of folate, B12 and pyridoxine (a combination that can lower homocysteine in the body) or placebo for three months. Clinical measures (e.g., PANSS, CGI) will be taken to determine whether those taking the vitamin combination experience clinical benefit.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Capsule with folate, Vitamin B12 & pyridoxine, placebo
- Keywords
- Schizophrenia, Schizoaffective Disorder, Homocysteine, Vitamins
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsule with folate, Vitamin B12 & pyridoxineDietary supplement
placeboOther
placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | vitamin capsule Receives: Dietary Supplement: Capsule with folate, Vitamin B12 & pyridoxine |
| B | Placebo comparator | placebo capsule Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood homocysteine levels
Measured: 12 weeks after baseline
Secondary outcomes (6)
CGI (Clinical Global Improvement)
Measured: 12 weeks after baseline
CDSS (Calgary Depression Scale for Schizophrenia)
Measured: 12 weeks after baseline
WAIS-II Memory Scale (Immediate and Delayed)
Measured: 12 weeks after baseline
WAIS Digit Symbol-Coding
Measured: 12 weeks after baseline
Wisconsin Card Sorting Test
Measured: 12 weeks after baseline
WAIS-II Letter-Number Sequencing Subtest
Measured: 12 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2006 (estimated)
- Study startJul 2004
- Study completionJul 2007
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nathan Kline Institute for Psychiatric Research
- Sponsor type
- University, hospital or other
- Collaborators
- Stanley Medical Research Institute
- Investigators
- William M Greenberg, M.D., Principal investigator, The Nathan Kline Institute for Psychiatric Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00403247
- Sponsor's protocol ID
- 04T-536
- Status last verified
- Aug 2007
- First submitted
- 22 Nov 2006
- Last updated
- 23 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind Vitamin Intervention to Lower Blood Homocysteine Levels: Amino Acid and Clinical Responses in Individuals With Schizophrenia.
- ClinicalTrials.gov ID
- NCT00403247
- Acronym / sponsor ID
- 04T-536
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Schizophrenia, Schizoaffective Disorder, Homocysteine, Vitamins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Nathan Kline Institute for Psychiatric ResearchUniversity, hospital or other
- Collaborators
- Stanley Medical Research Institute
- Study start
- Jul 2004
- Study completion
- Jul 2007 (actual)
- First posted
- 23 Nov 2006 (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 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.
Detailed description
Individuals with schizophrenia often experience disturbing residual symptoms, even with the best available current treatments. Homocysteine, normally found in the body, can interfere with NMDA-glutamate receptor function, and this might be responsible for some of the symptoms of schizophrenia. This double-blind protocol will have study participants who suffer from schizophrenia take either a high-dose combination of folate, B12 and pyridoxine (a combination that can lower homocysteine in the body) or placebo for three months. Clinical measures (e.g., PANSS, CGI) will be taken to determine whether those taking the vitamin combination experience clinical benefit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Dietary Supplement: Capsule with folate, Vitamin B12 & pyridoxinevitamin capsule |
| B | Placebo comparator | Other: placeboplacebo capsule |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Capsule with folate, Vitamin B12 & pyridoxine | Dietary supplement | A |
| placeboplacebo capsule | Other | B |
Primary outcome
blood homocysteine levels
Time frame: 12 weeks after baseline
6 secondary outcomes
CGI (Clinical Global Improvement)
Time frame: 12 weeks after baseline
CDSS (Calgary Depression Scale for Schizophrenia)
Time frame: 12 weeks after baseline
WAIS-II Memory Scale (Immediate and Delayed)
Time frame: 12 weeks after baseline
WAIS Digit Symbol-Coding
Time frame: 12 weeks after baseline
Wisconsin Card Sorting Test
Time frame: 12 weeks after baseline
WAIS-II Letter-Number Sequencing Subtest
Time frame: 12 weeks after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2007.
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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.
William M Greenberg, M.D. principal investigator
The Nathan Kline Institute for Psychiatric Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capsule with folate, Vitamin B12 & pyridoxine in people with Schizophrenia and Schizoaffective Disorder, run by Nathan Kline Institute for Psychiatric Research at 1 site 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 23 Aug 2007. 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 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
blood homocysteine levels (time frame: 12 weeks after baseline). 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 23 Aug 2007.