Recruiting

Observational Study

Sponsor:

Singula Institute

Code:

NCT05466851

Conditions

Depression

Anxiety Disorders

Stress Related Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Depression

Anxiety Disorders

Stress Related Disorder

Study ID

NCT05466851

Start date

Mar 1, 2023

Status verified date

Apr, 2024

Completion date

Mar 31, 2032

Anticipated

Primary completion date

Mar 31, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Treatment Engagement and Adherence [ Time Frame: Through Phase 1 completion, an average of 2-4 weeks ]
  • Treatment Response [ Time Frame: Through Phase II, an average of 3-6 months ]
  • Illness Remission & Treatment Maintenance [ Time Frame: Participants are to be followed by a clinician throughout their care over a period of weeks to months for the potential full course of treatment that is defined by specific clinical milestones. ]

Central Contacts and Locations

Central contacts

Jen Tung, RN, MA

2125315826info@singulainstitute.org

Jen Tung, RN, MA

2125315826jen.tung@singulainstitute.org

Locations

Singula Institute, 353 Lexington Avenue (Room 600)

Recruiting

New York, New York, United States, 10016

Contacts

Jen Tung, RN, MA

212-531-5826info@singulainstitute.org

Marc S Lener, MD

(240) 389-2381marc.lener@singulainstitute.org

More Information

Sponsor

Singula Institute

Last update posted

Apr 17, 2024

Last verified

Apr, 2024

Keywords

  • Biomarkers
  • Biopsychosocial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Singula Institute on 2024-04-17.