SchizophreniaPhase 4NCT00249288
Folate Supplementation in Schizophrenia
A Phase 4 study testing Folate in people with Schizophrenia, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study aims to examine factors potentially contributing to differences in blood folate, homocysteine or B12 levels between schizophrenia patients, to test the hypothesis that low folate is associated with negative symptoms, and to examine the efficacy of folate supplementation for reducing negative symptoms. Read more about this study
- Who is it for?
- Ages 18 to 68 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Folate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Jun 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Schizophrenia, any subtype
- Ages 18-68
- Male or female
- A score at least a 3 (moderate or greater severity) on at least one of the SANS global assessment subscales, with the exception of the attention global assessment subscale
- Stable antipsychotic dose for > 6 weeks
- Capable of providing informed consent
Who cannot join
- Unstable medical illness
- Substance abuse
- Megaloblastic anemia
- Non-english speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
This study aims to examine factors potentially contributing to differences in blood folate, homocysteine or B12 levels between schizophrenia patients, to test the hypothesis that low folate is associated with negative symptoms, and to examine the efficacy of folate supplementation for reducing negative symptoms.
Read the detailed description
This study is a three-month, placebo-controlled trial of folate 2mg/d in 50 schizophrenia patients who score at least a 3 (moderate or greater severity) on at least one of the SANS global assessment subscales, with the exception of the attention global assessment subscale. The specific aims of this study are:
- To examine factors potentially contributing to differences in blood folate, homocysteine or B12 levels between patients at baseline, including dietary intake and cigarette smoking.
- To test the hypothesis that low folate is associated with negative symptoms by examining correlations between red blood cell folate concentrations and clinical ratings of negative symptoms and by comparing folate concentrations in deficit syndrome versus non-deficit syndrome patients. We will also control for dietary intake cigarettes smoking, gender, and age.
- To examine the efficacy of folate supplementation for reducing negative symptoms
- Conditions
- Schizophrenia
- Being tested
- Folate, Placebo
- Keywords
- Schizophrenia, Negative Symptoms, Folate
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FolateDrug
Also called Folate or folic acid
Folic acid taken as 2, 1mg capsule daily for 12 weeks
PlaceboDrug
Placebo taken as 2, 1mg capsule daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Folate | Experimental | Participants will receive a 2 mg/ day dose of folate, for 12 weeks Receives: Drug: Folate |
| Placebo | Placebo comparator | Participants will receive a 2 mg/ day dose of placebo, for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Between Baseline Blood Folate and Smoking Status
Baseline blood folate lab levels are reported by smoking status.
Measured: Baseline
Correlation Between Baseline Blood Folate and MTHFR Genotype
Baseline blood folate lab levels are reported by MTHFR genotype.
Measured: Baseline
Correlation Between Baseline Blood Folate Levels and Dietary Intake
Baseline blood folate lab levels and dietary intake levels are reported.
Measured: Baseline
Efficacy of Folate Supplementation for Reducing Negative Symptoms as Measured by the SANS Modified Total
The change from baseline to week 12 on the scale for the assessment of negative symptoms (SANS) modified total score. Total SANS scores range from 0-100. The SANS is comprised of 5 sub-scales: Affective Flattening or Blunting (score range 0-35), Alogia (score range 0-20), Avolition-Apathy (score range 0-15), Anhedonia-Asociality (score range 0-20), and Attention (0-10). For each sub-scale, the higher the score the more prominent the negative symptoms were. The total score was computed by adding all the sub-scale total scores. To compute change in scores, baseline scores were subtracted from week 12 scores, resulting in a change score. Lower values signify greater improvement (i.e. week 12 score was lower than baseline score). The SANS modified total score is the SANS total score minus the Attention subscale.
Measured: Baseline score vs. week 12 score
Correlation Between Baseline Serum B12 Levels and Smoking Status
Baseline serum B12 lab levels are reported by smoking status.
Measured: Baseline
Correlation Between Baseline Homocysteine Levels and Smoking Status
Baseline blood homocysteine lab levels are reported by smoking status.
Measured: Baseline
Correlation Between Baseline Blood B12 Levels and MTHFR Genotype
Baseline blood B12 lab levels are reported by MTHFR genotype.
Measured: Baseline
Correlation Between Baseline Blood Homocysteine Levels and MTHFR Genotype
Baseline blood homocysteine lab levels are reported by MTHFR genotype.
Measured: Baseline
Correlation Between Baseline Serum B12 Levels and Dietary Intake
Baseline serum B12 lab levels and dietary intake levels are reported.
Measured: Baseline
Correlation Between Baseline Blood Homocysteine Levels and Dietary Intake
Baseline blood homocysteine lab levels and dietary intake levels are reported.
Measured: Baseline
Correlation Between Baseline Blood Folate or B12 Levels and Dietary Intake
Baseline blood folate and B12 lab levels and dietary intake levels are reported.
Measured: Baseline
Secondary outcomes (3)
Correlations Between Baseline Blood Folate and Clinical Ratings of Negative Symptoms by Comparing Lab Levels in Deficit Syndrome Versus Non-deficit Syndrome Patients
Baseline blood folate lab levels are reported by deficit syndrome status.
Measured: Baseline
Correlations Between Baseline Blood B12 Levels and Clinical Ratings of Negative Symptoms by Comparing Lab Levels in Deficit Syndrome Versus Non-deficit Syndrome Patients
Baseline blood B12 lab levels are reported by deficit syndrome status.
Measured: Baseline
Correlations Between Baseline Blood Homocysteine Levels and Clinical Ratings of Negative Symptoms by Comparing Lab Levels in Deficit Syndrome Versus Non-deficit Syndrome Patients
Baseline blood homocysteine lab levels are reported by deficit syndrome status.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2005 (estimated)
- Study startDec 2003
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Responsible party
- Principal investigator, Donald C. Goff, MD, Massachusetts General Hospital
- Investigators
- Donald C. Goff, M.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00249288
- Sponsor's protocol ID
- 2004P-000495
- Status last verified
- Mar 2018
- First submitted
- 3 Nov 2005
- Last updated
- 5 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hill M, Shannahan K, Jasinski S, Macklin EA, Raeke L, Roffman JL, Goff DC. Folate supplementation in schizophrenia: a possible role for MTHFR genotype. Schizophr Res. 2011 Apr;127(1-3):41-5. doi: 10.1016/j.schres.2010.12.006. Epub 2011 Feb 21.
PubMed 21334854
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Folate Supplementation in Schizophrenia
- ClinicalTrials.gov ID
- NCT00249288
- Acronym / sponsor ID
- 2004P-000495
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Negative Symptoms, Folate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Study start
- Dec 2003
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 7 Nov 2005 (estimated)
- Results
- Posted 6 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to examine factors potentially contributing to differences in blood folate, homocysteine or B12 levels between schizophrenia patients, to test the hypothesis that low folate is associated with negative symptoms, and to examine the efficacy of folate supplementation for reducing negative symptoms.
Detailed description
This study is a three-month, placebo-controlled trial of folate 2mg/d in 50 schizophrenia patients who score at least a 3 (moderate or greater severity) on at least one of the SANS global assessment subscales, with the exception of the attention global assessment subscale. The specific aims of this study are:
- To examine factors potentially contributing to differences in blood folate, homocysteine or B12 levels between patients at baseline, including dietary intake and cigarette smoking.
- To test the hypothesis that low folate is associated with negative symptoms by examining correlations between red blood cell folate concentrations and clinical ratings of negative symptoms and by comparing folate concentrations in deficit syndrome versus non-deficit syndrome patients. We will also control for dietary intake cigarettes smoking, gender, and age.
- To examine the efficacy of folate supplementation for reducing negative symptoms
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 |
|---|---|---|
| Folate | Experimental | Drug: FolateParticipants will receive a 2 mg/ day dose of folate, for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a 2 mg/ day dose of placebo, for 12 weeks |
Who may qualify
- Ages
- 18 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Schizophrenia, any subtype
- Ages 18-68
- Male or female
- A score at least a 3 (moderate or greater severity) on at least one of the SANS global assessment subscales, with the exception of the attention global assessment subscale
- Stable antipsychotic dose for > 6 weeks
Key exclusion criteria (4 listed)
- Unstable medical illness
- Substance abuse
- Megaloblastic anemia
- 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 |
|---|---|---|
| FolateAlso: Folate or folic acidFolic acid taken as 2, 1mg capsule daily for 12 weeks | Drug | Folate |
| PlaceboPlacebo taken as 2, 1mg capsule daily for 12 weeks | Drug | Placebo |
Primary outcome
Correlation Between Baseline Blood Folate and Smoking Status
Time frame: Baseline
Baseline blood folate lab levels are reported by smoking status.
Correlation Between Baseline Blood Folate and MTHFR Genotype
Time frame: Baseline
Baseline blood folate lab levels are reported by MTHFR genotype.
Correlation Between Baseline Blood Folate Levels and Dietary Intake
Time frame: Baseline
Baseline blood folate lab levels and dietary intake levels are reported.
Efficacy of Folate Supplementation for Reducing Negative Symptoms as Measured by the SANS Modified Total
Time frame: Baseline score vs. week 12 score
The change from baseline to week 12 on the scale for the assessment of negative symptoms (SANS) modified total score. Total SANS scores range from 0-100. The SANS is comprised of 5 sub-scales: Affective Flattening or Blunting (score range 0-35), Alogia (score range 0-20), Avolition-Apathy (score range 0-15), Anhedonia-Asociality (score range 0-20), and Attention (0-10). For each sub-scale, the higher the score the more prominent the negative symptoms were. The total score was computed by adding all the sub-scale total scores. To compute change in scores, baseline scores were subtracted from week 12 scores, resulting in a change score. Lower values signify greater improvement (i.e. week 12 score was lower than baseline score). The SANS modified total score is the SANS total score minus the Attention subscale.
Correlation Between Baseline Serum B12 Levels and Smoking Status
Time frame: Baseline
Baseline serum B12 lab levels are reported by smoking status.
Correlation Between Baseline Homocysteine Levels and Smoking Status
Time frame: Baseline
Baseline blood homocysteine lab levels are reported by smoking status.
Correlation Between Baseline Blood B12 Levels and MTHFR Genotype
Time frame: Baseline
Baseline blood B12 lab levels are reported by MTHFR genotype.
Correlation Between Baseline Blood Homocysteine Levels and MTHFR Genotype
Time frame: Baseline
Baseline blood homocysteine lab levels are reported by MTHFR genotype.
Correlation Between Baseline Serum B12 Levels and Dietary Intake
Time frame: Baseline
Baseline serum B12 lab levels and dietary intake levels are reported.
Correlation Between Baseline Blood Homocysteine Levels and Dietary Intake
Time frame: Baseline
Baseline blood homocysteine lab levels and dietary intake levels are reported.
Correlation Between Baseline Blood Folate or B12 Levels and Dietary Intake
Time frame: Baseline
Baseline blood folate and B12 lab levels and dietary intake levels are reported.
3 secondary outcomes
Correlations Between Baseline Blood Folate and Clinical Ratings of Negative Symptoms by Comparing Lab Levels in Deficit Syndrome Versus Non-deficit Syndrome Patients
Time frame: Baseline
Correlations Between Baseline Blood B12 Levels and Clinical Ratings of Negative Symptoms by Comparing Lab Levels in Deficit Syndrome Versus Non-deficit Syndrome Patients
Time frame: Baseline
Correlations Between Baseline Blood Homocysteine Levels and Clinical Ratings of Negative Symptoms by Comparing Lab Levels in Deficit Syndrome Versus Non-deficit Syndrome Patients
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21334854Hill M, Shannahan K, Jasinski S, Macklin EA, Raeke L, Roffman JL, Goff DC. Folate supplementation in schizophrenia: a possible role for MTHFR genotype. Schizophr Res. 2011 Apr;127(1-3):41-5. doi: 10.1016/j.schres.2010.12.006. Epub 2011 Feb 21.
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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.
Donald C. Goff, M.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Folate in people with Schizophrenia, run by Massachusetts General Hospital 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 6 inclusion and 4 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 5 Apr 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Correlation Between Baseline Blood Folate and Smoking Status (time frame: Baseline). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00249288, which also lists 1 linked publication.
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 5 Apr 2018.