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Identifying Biological Markers for Severe Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01831882
Recruitment Status : Completed
First Posted : April 15, 2013
Last Update Posted : August 21, 2020
Sponsor:
Collaborators:
Cornell University
University of California, Irvine
Pritzker Consortium
Information provided by (Responsible Party):
Alan Schatzberg, Stanford University

Brief Summary:
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.

Condition or disease
Major Depressive Disorder

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Study Type : Observational
Actual Enrollment : 210 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Identifying Biological Markers for Severe Depression
Actual Study Start Date : July 2013
Actual Primary Completion Date : August 2020
Actual Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Major Depressive Disorder
Healthy Control



Primary Outcome Measures :
  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 Outcome Measures:
  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.


Biospecimen Retention:   Samples With DNA
We will be retaining biospecimens including, whole blood, serum, hair and saliva tissues samples.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Inpatient hospitals, outpatient clinics, community.
Criteria

Inclusion criteria for depressed patients:

  1. Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) diagnosis of Unipolar Major Depressive Disorder with or without psychotic features.
  2. 21-item Hamilton Depression Rating Scale (HDRS) score greater than or equal to 21.
  3. Thase Core Endogenomorphic Scale score greater than or equal to 8 on the items included in the 21-item HDRS.
  4. Between 18 - 70 years of age.
  5. 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.
  6. Pre-existing (current) primary treating psychiatrist for subjects with psychotic features.
  7. 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:

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

Exclusion Criteria for depressed patients:

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

Exclusion criteria for healthy controls:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01831882


Locations
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United States, California
University of California, Irvine
Irvine, California, United States, 92697
Stanford University, Department of Psychiatry and Behavioral Sciences
Stanford, California, United States, 94305
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
Sponsors and Collaborators
Stanford University
Cornell University
University of California, Irvine
Pritzker Consortium
Investigators
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Principal Investigator: Alan Schatzberg, M.D. Stanford University
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Responsible Party: Alan Schatzberg, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01831882    
Other Study ID Numbers: 26529
First Posted: April 15, 2013    Key Record Dates
Last Update Posted: August 21, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders