An Exploratory Study Examining Biopsychosocial Markers of Anxiety and Depression

Launched by SINGULA INSTITUTE · Jul 18, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring the different factors that contribute to anxiety and depression. Researchers want to understand how a mix of personal thoughts, feelings, biology, and social influences can affect how individuals experience these mental health conditions and respond to various treatments. The study will look at many aspects, including inflammation, hormone levels, personality, and support from friends and family, to see how they might play a role in treatment success.

To participate, individuals must be between 18 and 65 years old and have been diagnosed with major depression or certain anxiety disorders. Participants will engage in therapy and medication management, setting personal treatment goals and sharing updates through videos about their experiences. This study aims to gather valuable information that could improve the diagnosis and treatment of anxiety and depression for others in the future.

Gender

ALL

Eligibility criteria

• 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.