Clinical Trials

Inclusion Criteria - Patients:

• Age 18-65 years.
• Currently depressed patients [n=100 major depressive disorder (MDD), n=100 bipolar (50 BPI, 50 BII)] confirmed by Mini International Neuropsychiatric Interview (MINI) active in clinical care.
• Use a compatible smartphone. If participant has smart watch, that will be used for additional data collection and comparison to smart phone data collection. If participants do not have a watch, and are interested, a smartwatch will be offered for the 12 week trial.

Inclusion Criteria - Healthy Controls:

• Age 18-65 years old.
• 100 age- and sex- matched controls as confirmed by Mini International Neuropsychiatric Interview (MINI).
• Use a compatible smart phone. If participating has smart watch, that will be used for additional data collection and comparison to smart phone data collection. If participants do not have a watch, and are interested, an accelerometer will be offered for the 12 week trial.

Exclusion Criteria

For patients:

• Inability to understand written or spoken English;
• Inability to provide valid written informed consent because of an identified/diagnosed intellectual disability, an organic brain syndrome, or any other reason, as per the judgment of the team physician;
• Primary reasons for treatment are not related to depression  (e.g., are due to an adjustment disorder, personality disorder effect of substances or substance abuse, or exacerbation of a comorbid psychiatric disorder) based on available information, review of EHR, and/or investigator judgement
• Psychotic disorder or current psychotic features;
• Active suicidal ideation (QIDS-C question 12 score of >2 and investigator judgement)
• Involuntary admission to inpatient unit.
• Women with known pregnancy at time of enrollment*
• Active abuse or dependence of alcohol, opiates, or cannabis (nicotine dependence will be an exception) by structured clinical interview for DSM-IV-TR; patients meeting full remission for at least 3 months can be randomized. 

For Healthy Controls:

• Inability to understand written or spoken English;
• Inability to provide valid written informed consent because or mental retardation, an organic brain syndrome, or any other reason, as per the judgment of the team physician.
• Has had a current  psychiatric diagnosis within the last year.
• Currently taking a psychotropic medication.
• Women with known pregnancy at time of enrollment*

* Healthy controls will not be receiving any psychiatric treatment during the study. For depressed female patients of child bearing potential who will be followed naturalistically, it is possible they may receive pharmacotherapy or other clinical intervention from her mental health provider. It will be up to the clinician providing care to determine the need to clarify the pregnancy status.

* If a patient or healthy control becomes pregnant at anytime throughout the study, the patient will be withdrawn from the study.

Eligibility last updated 12/12/22.  Questions regarding updates should be directed to the study team contact.