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 @ 11:11 PM
Ignite Modification Date:
2025-12-24 @ 11:11 PM
NCT ID:
NCT01583569
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 and \< 65.
* Meet DSM-IV criteria for MDD (n=5), BD (n=5), or healthy controls with no psychiatric diagnosis (n=5).
* Willing and able to wear a wearable device to measure sleep parameters
* Willing and able to provide voice samples.
* Subjects with MDD must not be taking psychiatric medications at the time of evaluation.Subjects with BD can be taking psychiatric medications, since it is not feasible for patients with BD to be completely free of mood stabilizing medications. These medications will be limited to lithium, second generation antipsychotics.
* Currently a patient or research participant at the DCRP or the BCRP or are healthy controls enrolled in evaluation studies.
Exclusion Criteria:
* Primary sleep disorder, including restless legs syndrome, difficulties in initiating and maintaining sleep.
* Movement disorders (e.g. Parkinson's, Huntington's, tardive dyskinesia, primary chorea).
* Active substance abuse or dependence in the past 3 months.
* Cardiovascular or pulmonary disease, including uncontrolled hypertension, arrhythmias, history of myocardial infarction, asthma, COPD, or pulmonary carcinoma.
* Cardiovascular or pulmonary medications (aspirin and statins are allowable).
* Anticonvulsants.
* Sedative/hypnotics (e.g. benzodiazepines, eczopiclone).
* Smokers.
* Pregnancy.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01583569
Study Brief:
Protocol Section:
NCT01583569