Identifying Biological Markers for Severe Depression

• ClinicalTrials.gov Identifier: NCT01831882
• Recruitment Status: Completed
• First Posted: April 15, 2013
• Last Update Posted: August 21, 2020
• Sponsor: Stanford University
• Collaborators: Cornell University; University of California, Irvine; Pritzker Consortium
• Information provided by (Responsible Party): Alan Schatzberg, Stanford University

Study Description

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

Study Design

• 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

Groups and Cohorts

Group/Cohort
Major Depressive Disorder
Healthy Control

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Principal Investigator: Alan Schatzberg, M.D.; Stanford University

More Information

• Responsible Party: Alan Schatzberg, Principle Investigator, Stanford University
• ClinicalTrials.gov Identifier: NCT01831882
• Other Study ID Numbers: 26529
• First Posted: April 15, 2013
• Last Update Posted: August 21, 2020
• Last Verified: August 2020

Additional relevant MeSH terms:

Depressive Disorder; Depressive Disorder, Major; Mood Disorders; Mental Disorders