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 @ 5:48 PM
Ignite Modification Date:
2025-12-24 @ 5:48 PM
NCT ID:
NCT02573168
Eligibility Criteria:
Inclusion Criteria:
1. 18 years of age or older;
2. Suffer from schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis not otherwise specified, bipolar disorder (I, II, NOS) or major depressive disorder meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria;
3. Have moderate to severe psychiatric symptoms;
4. Intending to switch to, or start a new antipsychotic medication;:
5. Be capable and willing to provide written informed consent to participate in this study;
6. Agree to abide by the study protocol and its restrictions and be able to complete all aspects of the study, including all visits and tests.
Exclusion Criteria:
1. Patients posing a serious suicidal risk and/or violence as judged by the investigator;
2. Patients with a current Axis I diagnosis of:
* Delirium
* Dementia
* Amnestic and other cognitive disorder;
3. Patients who are on restricted diets (e.g., diabetes), who have an eating restriction disorder (e.g., bulimia, anorexia), or who are undergoing weight-reducing interventions (e.g. metformin, or structured diet program).
4. Patients with a history of hypothyroidism unless taking a stable dose of thyroid medication and asymptomatic or euthyroid for 6 months;
5. Patients who meet DSM-IV-TR criteria for any significant current substance dependence;
6. Patients with:
* hepatic insufficiency (three times the upper limit of normal (ULN) for aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)); liver transplant recipient; cirrhosis of the liver;
* malignancy (except basal cell carcinoma) and/or chemotherapy within 1 year prior to screening; malignancy more than 1 year prior to screening must have been local and without metastasis and/or recurrence, and if treated with chemotherapy, without nervous system complications;
* significant unstable medical condition or life threatening disease with anticipated survival of less than 6 months;
* need for therapies that may obscure the results of treatment and/or of the study
7. Participation in another clinical trial within 30 days of the screening visit;
8. Anticipated inability to attend scheduled study visits;
9. Patients who in the judgment of the Investigator may be unreliable or uncooperative with the evaluation procedure outlined in this protocol;
10. Patients with a history of prior pharmacogenomic testing;
11. Any change in psychotropic medication (including change in dosage) between screening and baseline;
12. Patients who are known to be pregnant or lactating;
13. Patients with a history of gastric bypass surgery.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02573168
Study Brief:
Protocol Section:
NCT02573168