Long-term Observation of Participants With Mood Disorders
To learn the long-term impact of depression, bipolar disorder, and suicide risk.
Detailed Description
This prospective cohort follow-up (up to 1 year per participant) will re-contact former participants of Protocol 01-M-0254 to assess long-term depressive symptoms, suicide attempts, and ketamine utilisation via online surveys and telephone interviews.
Design comprises two remote phases: Phase 1 online surveys (~30 minutes) assessing current symptoms and treatments; Phase 2 telephone interviews (1–4 hours) for in-depth clinical and treatment history.
Primary endpoint is Beck Depression Inventory score; secondary endpoints include self-reported suicide attempts, self-reported ketamine use, and suicide mortality via National Death Index linkage.
Study Arms & Interventions
Healthy Volunteers
experimentalIndividuals who previously signed consent for ETPB research as healthy volunteers
Mood Disorder Patients
experimentalIndividuals with mood disorders who previously signed consent for ETPB research
Participants
Inclusion Criteria
- INCLUSION CRITERIA:
- 1. Participants who signed consent for Protocol 01-M-0254: The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers over a year ago.
- 2. Age 18 years or older
- 3. Able to provide informed consent online using study website or over the telephone
- 4. Able to read and write English
- EXCLUSION CRITERIA:
- None.
Exclusion Criteria
- None.
Study Details
- StatusRecruiting
- PhasePhase NA
- Typeobservational
- DesignNon-randomized
- Target Enrollment1000 participants
- TimelineStart: 2021-06-17End: 2023-10-01
- Topic