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Understanding Anxiety and Depression: An Observational Study

This study is looking at how different factors, like your thoughts, feelings, surroundings, and biology, might influence anxiety and depression. Researchers want to understand why people experience these conditions and why certain treatments work better for some individuals than others. They are also exploring what helps people stay in treatment and what leads to positive or negative treatment results. This research will gather a wide range of information to help us better understand these complex conditions. You may be able to join if you are between 18 and 65 years old and have been diagnosed with Major Depression. The study will look at how well you engage with and stick to treatment, your response to treatment, and whether your illness goes into remission and stays that way.

Study design
This is an observational study aiming to enroll 200 participants. It is not testing a specific intervention or drug.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed by a clinician throughout their care for the potential full course of treatment, which could last weeks to months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05466851

An Exploratory Study Examining Biopsychosocial Markers of Anxiety and Depression

Recruiting
Not specifiedAges 18–65Observational
Singula Institute
~200 participants
Updated 2024-04-17 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Treatment Engagement and Adherence
Measured over Through Phase 1 completion, an average of 2-4 weeks
+2 more outcomes measured

Conditions

Depression
Anxiety Disorders
Stress Related Disorder

Explore related trials

Anxiety DisorderAttention Deficit Hyperactivity DisorderObsessive Compulsive DisorderPost-Traumatic Stress DisorderUnipolar Depression

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Marc S Lener, M.D. · PRINCIPAL_INVESTIGATOR · CEO

Who to contact

Jen Tung, RN, MA
[email protected]
2125315826
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Treatment Engagement and AdherenceThrough Phase 1 completion, an average of 2-4 weeks

    To identify biopsychosocial correlates of treatment engagement and adherence through Neurocognitive measures of cognitive flexibility (cognitive control, executive functioning, task inhibition) and delayed gratification, biological markers of stress and inflammation, perceived psychological stress, anxiety, mood, loneliness, and stigma, and video recorded affective responses to prompts.

  • Treatment ResponseThrough Phase II, an average of 3-6 months

    To identify biopsychosocial correlates of treatment response through Neurocognitive measures of cognitive flexibility (cognitive control, executive functioning, task inhibition) and delayed gratification, biological markers of stress and inflammation, perceived psychological stress, anxiety, mood, loneliness, and stigma, and video recorded affective responses to prompts.

  • Illness Remission & Treatment MaintenanceParticipants 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.

    To identify biopsychosocial correlates of illness remission and treatment maintenance through Neurocognitive measures of cognitive flexibility (cognitive control, executive functioning, task inhibition) and delayed gratification, biological markers of stress and inflammation, perceived psychological stress, anxiety, mood, loneliness, and stigma, and video recorded affective responses to prompts.