Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2025-12-24 @ 1:12 PM
NCT ID:
NCT01075295
Eligibility Criteria:
Inclusion Criteria:
* Age between 14 and 45 years (inclusive)
* Male or Female gender
* DSM-IV-TR diagnosis of Schizophrenia, Schizoaffective disorder,Schizophreniform Disorder, Bipolar Disorder (Type I),Bipolar Disorder (Type II), Major Depressive Disorder With Psychotic Features, Substance-Induced Psychoses, Psychosis Not-Otherwise-Specified (NOS)
* Outpatient status at the time of randomization
* Duration of antipsychotic treatment of less than 5 years
* Ability to provide informed consent
* Female patients of childbearing potential must be using a medically accepted means of contraception
* Treatment with olanzapine, clozapine, quetiapine,risperidone or paliperidone for less than 8 weeks duration at enrollment
* BMI between 18.5 and 30
Exclusion Criteria:
* Inability to give informed consent
* Currently enrolled in a weight management program
* Currently being treated with a medication to reduce weight
* Patients with unstable or active cardiovascular illnesses (myocardial infarction, congestive heart failure, etc), active or end-stage renal disease, and unstable thyroid disease, etc
Inclusion/exclusion criteria has been intentionally limited in order to maximize the generalizability of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
45 Years
Study:
NCT01075295
Study Brief:
Protocol Section:
NCT01075295