An Exploratory Study Examining Biopsychosocial Markers of Anxiety and Depression
Recruiting · NCT05466851 · Observational (researchers observe without assigning treatment) · Lead sponsor: Singula Institute
View the official record on ClinicalTrials.gov →What this trial is about
This research study is studying how thoughts, feelings, surroundings, and individual biology may contribute to why and how people experience anxiety or depression. We are trying to find out the wide variety of reasons that people may experience anxiety or depression, and why different people are helped by different forms of treatment. We are trying to determine why people stay in treatment, and what factors contribute to a positive or negative response to treatment. These reasons may be due to thoughts, feelings, beliefs, personality, biology, social support network, life events, and barriers to treatment. A wide range of information about factors that impact anxiety and depression will be included. These include, among others, measures of inflammation, hormone levels, behavior, spoken language, personality, medical history, social determinants of health, and attitudes toward mental health and its treatment. The study involves psychological and psychiatric treatments in the form of psychotherapy and medication management. The participant will be asked to set specific goals for study treatment, and to provide videos between sessions about relevant medication, emotional, and sleep factors in their life. In summary, this study will collect biological, psychological, and social factors that may play a role in anxiety and depression. This will inform both individual's diagnosis and treatment and will be used in a later set of analyses that can inform diagnosis and treatment for other individuals who share similar characteristics.
Who can take part
Inclusion criteria
- 18 to 65 years of age.
- Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.
- At the initial study enrollment, subjects must have fulfilled DSM-5 criteria for Major Depression, single episode or recurrent.
- At the initial study enrollment, subjects may have fulfilled DSM-5 criteria for an Anxiety Disorder Comorbid Psychiatric Disorders, specifically Anxiety Disorders (Panic Disorder, Specific Phobia, Social Anxiety Disorder, Generalized Anxiety Disorder), Obsessive Compulsive Disorder, or a prior diagnosis of Post-Traumatic Stress Disorder, and/or Attention Deficit Hyperactivity Disorder may be enrolled as per assessment and agreement of evaluating clinicians.
- Agree to participate in clinical treatment (medication management and psychotherapy)
Exclusion criteria
- Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
- History of head trauma or stroke (also known as a cerebrovascular accident).
- Clinically significant abnormal laboratory tests.
- Subjects with one or more seizures without a clear and resolved etiology or current use of medication known to lower seizure threshold.
- Any use of opioid medication in the past 12 months
- Positive HIV test
- Current psychotic features or a diagnosis of Schizophrenia or any other psychotic disorder as defined in the DSM-IV.
- Subjects with a history of DSM-IV drug or alcohol dependency or abuse (except for caffeine or nicotine dependence) within the preceding 12 months. In addition, subjects who currently are using drugs (except for caffeine or nicotine) must not have used illicit substances or known drugs of abuse in the 2 weeks prior to screen
- Subjects who, in the investigator's judgment, pose a current serious suicidal or homicidal risk.
Where it is running
1 location listed across 1 US state.
- Singula Institute, 353 Lexington Avenue (Room 600) - New York, New York, United States