Schizophrenia Clinical Trial
Official title:
Vitamin-D Treatment Targeted to Hyperprolinemia-Associated Schizophrenia.
NCT number | NCT02197286 |
Other study ID # | S13-01127 |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 2 |
First received | July 16, 2014 |
Last updated | October 7, 2015 |
Start date | February 2015 |
A ten week, blinded trial of vitamin D vs. placebo in 80 patients with schizophrenia or schizoaffective disorder who have low blood levels of vitamin D and elevated blood levels of the amino acid proline. The aims of the study are to evaluate an anticipated clinical response to vitamin D supplementation including negative symptoms and cognitive deficits, evaluate safety of vitamin D supplementation for schizophrenia patients and evaluate the relationship of changes in plasma proline levels and efficacy outcomes.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: Inclusion Criteria for Recruitment 1. Male and Female, all racial/ethnic groups, aged 18-65 years. 2. Admission diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder. 3. Capability to give informed consent. Inclusion Criteria for Randomization and Trial Entry 1. Fasting hyperprolinemia (defined as 2 standard deviations (SDs) above the gender-adjusted mean measured for historical controls: 203.3 micromolar (uM) for females and 327.6 uM for males). 2. 25(OH)D insufficiency (<30ng/ml). 3. Confirmed diagnosis of schizophreniform disorder, schizophrenia or schizoaffective disorder. Exclusion Criteria: Exclusion Criteria for Recruitment 1. Organic brain disorders. 2. Valproate treatment within 14 days, because of known proline up-regulatory effects. 3. Pregnant women or women of child-bearing potential, who are not surgically-sterile or who are not using appropriate methods of birth control. 4. Amino acid metabolism disorder diagnosis. 5. Hypercalcemia (>10.4mg/dL), hypercalciuria (>0.20mg/mg), hyperthyroidism (>65pg/ml) or history of renal stones, kidney disease, atherosclerosis, sarcoidosis, histoplasmosis and lymphoma. 6. Chart record of HIV positive status. 7. Treatment with clozapine, as this may reflect general treatment resistance. Exclusion Criteria for Randomization and Trial Entry 1. Abnormal serum/ urine metabolic lab values suggesting hypercalcemia (serum Calcium >10.4mg/dL), hypercalciuria (urine calcium/urine creatinine >0.20 mg/mg), or hyperthyroidism (parathyroid hormone (PTH) > 65pg/ml). 2. Initiation of Valproate treatment. 3. Continued use of dietary supplementation, such as fish oil supplementation or vitamin D supplements (>400 IU/day). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Bellevue Hospital Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
New York University School of Medicine | Columbia University, Stanley Medical Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Length of hospital stay. | Firstly, compare the length of hospitalization between study arms. Secondly, measure plasma proline levels and peripheral gene expression, and examine the relationship via regression modeling, with the length of hospitalization. | Lead-in phase visit, baseline visit and then at biweekly visits until discharge, an expected average period from lead-in to discharge of seven weeks. | No |
Other | Number of participants with adverse events as a measure of safety. | To evaluate the safety of vitamin D supplementation for schizophrenic or schizoaffective patients, by collecting data on all adverse events. | Throughout 10 week treatment study period. | Yes |
Other | Clinical response to supplementation with vitamin D. | To evaluate a clinical response to vitamin D supplementation by the change in the Brief Ratings Psychiatric Scale. | Baseline (start of vitamin D supplementation) through ten weeks of treatment. | No |
Other | Clinical response to supplementation with vitamin D. | To evaluate a clinical response to vitamin D supplementation by the change in the Wechsler Adult Intelligence scale. | Baseline (start of vitamin D supplementation) through ten weeks of treatment. | No |
Other | Clinical response to supplementation with vitamin D. | To evaluate a clinical response to vitamin D supplementation by the change in the Clinical Global Impression scale. | Baseline (start of vitamin D supplementation) through ten weeks of treatment. | No |
Primary | Clinical response to supplementation with vitamin D. | To evaluate an anticipated clinical response to supplementation with vitamin D including negative symptoms and cognitive deficits by the change in the Positive and Negative Symptom Scale (PANSS) total score and the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) consensus cognitive scale. Secondary outcomes will also involve investigation of individual domains of the PANSS and MATRICS. | Baseline (start of vitamin D supplementation) through ten weeks of treatment. | No |
Secondary | Biological response to supplementation with vitamin D. | Measure plasma proline levels and peripheral PRODH gene expression levels, and examine the relationship with clinical symptoms and cognitive deficits for efficacy biomarker development. | Lead-in phase visit, baseline visit and then at biweekly visits through ten weeks of treatment. | No |
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