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Completed

NCT Number: NCT01831882

Identifying Biological Markers for Severe Depression

The primary objective of this study is to investigate the biological components of major depression. The investigators are particularity interested in genetic variation and how it contributes to cortisol (because cortisol is higher in severe depression than mild depression or healthy controls) and how it contributes to clinical symptoms, especially suicidal ideation/behavior and psychosis.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, Irvine, Irvine, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for depressed patients:

  • Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) diagnosis of Unipolar Major Depressive Disorder with or without psychotic features.
  • 21-item Hamilton Depression Rating Scale (HDRS) score greater than or equal to 21.
  • Thase Core Endogenomorphic Scale score greater than or equal to 8 on the items included in the 21-item HDRS.
  • Between 18 - 70 years of age.
  • If currently taking antipsychotic, antidepressant, anticonvulsant, and/or mood-stabilizing medications, must be stable on the medication for at least one-week prior to entering the study.
  • Pre-existing (current) primary treating psychiatrist for subjects with psychotic features.
  • Any secondary diagnoses from the anxiety disorder spectrum is acceptable. Primary pre-existing chronic Obsessive-Compulsive Disorder (OCD) will be an exclusion criteria.

Inclusion criteria

for healthy controls:

  • Between 18 - 70 years of age.
  • Have a HAM-D score of less than or equal to 5.

Exclusion criteria

for depressed patients:

  • Electroconvulsive Therapy (ECT) in the 6 months prior to the study.
  • Abuse of drugs or alcohol in the 6 months prior to study.
  • Unstable or untreated hypertension or cardiovascular disease.
  • Use of additional prescription medications, street drugs, or alcohol during the week before the study.
  • Any Axis II diagnosis or traits which would make participation in the study difficult.
  • Current pregnancy or lactation.
  • Post-partum depression
  • Diagnosis of obsessive-compulsive disorder
  • History of significant cognitive decline

Exclusion criteria

for healthy controls:

  • Personal history of Axis I or Axis II disorders.
  • Active unstable medical problems.
  • Abuse of drugs or alcohol in the 6 months prior to study.
  • Use of additional prescription medications, street drugs, or alcohol during the week before the study.
  • Currently pregnant or lactating.
  • History of significant cognitive decline

Treatment and study plan

Primary outcomes

  1. Genetics

    Time frame: 1 year

    Blood will be drawn for gene expression, which includes genetics and metallothionein assessments. Blood will also be drawn for later assay of immune function/measures and neurotophins, and for future studies.

Other outcomes

  1. Physiologic

    Time frame: 1 year

    Cortisol hormone levels will be measured in blood (suppression test), hair and saliva samples.

  2. Neurocognition

    Time frame: 1 year

    Standardized neuropsychological measures will be used to assess neurocognition including, tests involving verbal learning, visual reproduction, attentional flexibility, and memory.

  3. Clinical

    Time frame: 1 year

    Clinical psychiatric measures will be used to assess depression (HAM-D), psychotic features, suicidality, childhood trauma, and anhedonia.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Cornell University
  • Pritzker Consortium
  • University of California, Irvine

Registry information

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
Apr 15, 2013
Registry last updated
Aug 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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