Status:
COMPLETED
The Influence of Vitamin D on Atypical Antipsychotic-induced Weight Gain
Lead Sponsor:
Creighton University
Conditions:
Schizophrenia
Metabolic Syndrome
Eligibility:
All Genders
21-65 years
Brief Summary
Schizophrenia and bipolar disorders are major public health problems. The second generation anti-psychotic drugs have efficacy for both positive and negative symptoms and a favorable risk profile as f...
Detailed Description
Specific Aim: We predict that the patients with schizophrenia, who gain weight with antipsychotic treatment, are vitamin D-deficient compared to the patients who do not gain weight. We will examine ci...
Eligibility Criteria
Inclusion
- • Men and women with a DSM-IV clinical diagnosis of Schizophrenia, Schizoaffective or Bipolar disorder
- 21 to 65 years of age; male and female
- A willingness and ability to provide signed informed consent
- The subject should have been on quetiapine 100 mg or more for more than 12 weeks.
Exclusion
- Pregnant women
- Subjects considered at high suicide risk based on the MINI Suicidality Module (\> 17 points)
- Unstable general medical condition or serious illness (e.g. death or hospitalization is anticipated within one year), poor kidney function or liver function (defined as laboratory values ≥ three times the upper limit of the normal), and seizure disorders except for childhood seizure disorders
- Concurrent therapy with certain psychotropics is permitted, provided that the medication and dose have been stable for the past 90 days
- Patients on concomitant treatment with clozapine and olanzapine are not permitted.
- Patients on immunosuppressant medications or any orexigenic or anorexigenic drug
- Patients on concomitant treatment with amphetamines and/ or methylphenidate
- History of hypothyroidism or thyroxine therapy
- Patients with a known condition or undergoing therapeutic measures that affects weight, including but not limited to: eating disorder, type I diabetes, hyperthyroidism, thyroxine therapy, Topamax therapy, and infectious diseases, such as HIV, hepatitis B, and hepatitis C
- Active supplementation of vitamin D within the last 3 months
Key Trial Info
Start Date :
November 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02281162
Start Date
November 1 2014
End Date
September 1 2015
Last Update
January 8 2016
Active Locations (1)
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1
Alegent Creighton Clinic - Psychiatric Associates (Dodge Street)
Omaha, Nebraska, United States, 68132