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Effectiveness of Vitamin Supplementation in Treating People With Residual Symptoms of Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Donald C. Goff, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00611806
First received: February 7, 2008
Last updated: July 31, 2014
Last verified: July 2014
Results First Received: July 31, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Dietary Supplement: Folic Acid
Dietary Supplement: B12
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
189 Participants were screened for enrollment, but 49 were excluded. 40 were ineligible, 2 withdrew consent, 1 terminated because of an adverse event, and 6 were terminated because of study visit noncompliance.

Reporting Groups
  Description
Folate With B12

Participants will take folic acid plus B12 for 18 weeks.

Folic Acid: Folic acid 2mg po daily

B12: B12 400 micrograms po daily

Placebo

Participants will take placebo for 18 weeks.

Placebo: 1 capsule po daily


Participant Flow:   Overall Study
    Folate With B12   Placebo
STARTED   94   46 
COMPLETED   78   43 
NOT COMPLETED   16   3 
Withdrawal by Subject                8                2 
Adverse Event                2                1 
Lost to Follow-up                6                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Folate With B12

Participants will take folic acid plus B12 for 18 weeks.

Folic Acid: Folic acid 2mg po daily

B12: B12 400 micrograms po daily

Placebo

Participants will take placebo for 18 weeks.

Placebo: 1 capsule po daily

Total Total of all reporting groups

Baseline Measures
   Folate With B12   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 94   46   140 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.3  (1.1)   45.9  (1.6)   45.6  (1.35) 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   94   46   140 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   28   32   60 
Male   66   14   80 
Region of Enrollment 
[Units: Participants]
     
United States   94   46   140 


  Outcome Measures
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1.  Primary:   Positive and Negative Syndrome Scale (PANSS)   [ Time Frame: Baseline vs. Week 16 ]

2.  Secondary:   Positive Sub Scale of the Positive and Negative Syndrome Scale (PANSS)   [ Time Frame: Baseline vs. Week 16 ]

3.  Secondary:   Scale for Assessment of Negative Symptoms (SANS)   [ Time Frame: Baseline vs. Week 16 ]

4.  Secondary:   Positive and Negative Syndrome Scale (PANSS) and FOLH1, MTHRF, MTR, and COMT Genotype   [ Time Frame: Baseline vs. Week 16 ]

5.  Secondary:   Cognitive Deficits, as Measured by the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Cognitive Battery Composite Score   [ Time Frame: Measured at Week 16 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Relationship Between Response of Negative and Positive Symptoms and the Change in RBC Folate, Serum Folate, Serum B12, and Plasma Homocysteine Concentrations   [ Time Frame: Measured at Week 16 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   0  

Reporting Groups
  Description
Folate With B12

Participants will take folic acid plus B12 for 18 weeks.

Folic Acid: Folic acid 2mg po daily

B12: B12 400 micrograms po daily

Placebo

Participants will take placebo for 18 weeks.

Placebo: 1 capsule po daily


Other Adverse Events
    Folate With B12   Placebo
Total, other (not including serious) adverse events     
# participants affected / at risk   21/94 (22.34%)   16/46 (34.78%) 
Cardiac disorders     
Tachycardia †     
# participants affected / at risk   1/94 (1.06%)   0/46 (0.00%) 
# events   1   0 
Endocrine disorders     
Hypoglycemia †     
# participants affected / at risk   1/94 (1.06%)   0/46 (0.00%) 
# events   1   0 
Eye disorders     
Eye Blood Shot †     
# participants affected / at risk   0/94 (0.00%)   1/46 (2.17%) 
# events   0   1 
Vision Decreased †     
# participants affected / at risk   0/94 (0.00%)   1/46 (2.17%) 
# events   0   1 
Gastrointestinal disorders     
Cholelithiasis †     
# participants affected / at risk   1/94 (1.06%)   0/46 (0.00%) 
# events   2   0 
Dirrhea †     
# participants affected / at risk   1/94 (1.06%)   0/46 (0.00%) 
# events   1   0 
Dry Mouth †     
# participants affected / at risk   1/94 (1.06%)   0/46 (0.00%) 
# events   1   0 
Nausea †     
# participants affected / at risk   0/94 (0.00%)   1/46 (2.17%) 
# events   0   1 
Vomiting †     
# participants affected / at risk   0/94 (0.00%)   1/46 (2.17%) 
# events   0   1 
General disorders     
Back Pain †     
# participants affected / at risk   0/94 (0.00%)   1/46 (2.17%) 
# events   0   1 
Chest Pain †     
# participants affected / at risk   0/94 (0.00%)   1/46 (2.17%) 
# events   0   1 
Malaise †     
# participants affected / at risk   1/94 (1.06%)   0/46 (0.00%) 
# events   1   0 
Laboratory Test Abnormality †     
# participants affected / at risk   1/94 (1.06%)   0/46 (0.00%) 
# events   1   0 
Infections and infestations     
Infection †     
# participants affected / at risk   1/94 (1.06%)   0/46 (0.00%) 
# events   1   0 
Nervous system disorders     
Constipation     
# participants affected / at risk   2/94 (2.13%)   0/46 (0.00%) 
# events   2   0 
Numbness †     
# participants affected / at risk   0/94 (0.00%)   1/46 (2.17%) 
# events   0   1 
Dizziness †     
# participants affected / at risk   0/94 (0.00%)   1/46 (2.17%) 
# events   0   1 
Injury †     
# participants affected / at risk   0/94 (0.00%)   1/46 (2.17%) 
# events   0   1 
Insomnia †     
# participants affected / at risk   1/94 (1.06%)   0/46 (0.00%) 
# events   1   0 
Muscle Spasm †     
# participants affected / at risk   1/94 (1.06%)   0/46 (0.00%) 
# events   1   0 
Somnolence †     
# participants affected / at risk   1/94 (1.06%)   1/46 (2.17%) 
# events   1   1 
Brain Tumor †     
# participants affected / at risk   0/94 (0.00%)   1/46 (2.17%) 
# events   0   1 
Psychiatric disorders     
Delusions †     
# participants affected / at risk   0/94 (0.00%)   1/46 (2.17%) 
# events   0   2 
Manic Psychosis †     
# participants affected / at risk   1/94 (1.06%)   0/46 (0.00%) 
# events   1   0 
Psychosis †     
# participants affected / at risk   3/94 (3.19%)   1/46 (2.17%) 
# events   3   1 
Suicidal Tendency †     
# participants affected / at risk   1/94 (1.06%)   0/46 (0.00%) 
# events   1   0 
Renal and urinary disorders     
Enuresis †     
# participants affected / at risk   1/94 (1.06%)   0/46 (0.00%) 
# events   1   0 
Respiratory, thoracic and mediastinal disorders     
Asthema †     
# participants affected / at risk   0/94 (0.00%)   1/46 (2.17%) 
# events   0   1 
Skin and subcutaneous tissue disorders     
Irritation of Skin †     
# participants affected / at risk   1/94 (1.06%)   0/46 (0.00%) 
# events   1   0 
Rash †     
# participants affected / at risk   1/94 (1.06%)   0/46 (0.00%) 
# events   1   0 
Urticaria †     
# participants affected / at risk   0/94 (0.00%)   2/46 (4.35%) 
# events   0   2 
Events were collected by systematic assessment
* Events were collected by non-systematic assessment



  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Joshua L. Roffman, MD
Organization: Massachusetts General Hospital
phone: 617-724-1920
e-mail: jroffman@partners.org


Publications of Results:

Responsible Party: Donald C. Goff, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00611806     History of Changes
Other Study ID Numbers: R01MH070831 ( US NIH Grant/Contract Award Number )
DATR A5-ETPD
Study First Received: February 7, 2008
Results First Received: July 31, 2014
Last Updated: July 31, 2014
Health Authority: United States: Federal Government