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:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT01615367
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Bipolar Disorder (Type I or II), which is the primary focus of treatment
* Ability to give informed consent
* Currently ill (CGI-BP ≥ 3)
* Age \> 18 years and \< 65 years
* Overweight individuals (BMI \> 25)
Exclusion Criteria:
* Unwilling/unable to comply with study procedures
* Endorsed item, confirmed by patient's physician, on the PAR-Q
* Euthymic (CGI-BP \< 3)
* Diagnosis of an eating disorder (e.g., anorexia nervosa, bulimia nervosa) in the past month
* Diagnosis of substance dependence in the past month
* Active suicidality (MADRS item 9 score \> 4)
* Pregnant (as analyzed by a urine pregnancy test)
* Currently receiving another psychosocial treatment
* Exercising regularly (i.e., 5 days per week for 30 min)
* Neurologic disorder or history of head trauma
* Contraindications to exercise or diet interventions (e.g., co-morbid nutritional and metabolic diseases, physical injuries)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01615367
Study Brief:
Protocol Section:
NCT01615367