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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder

• Study Type: Observational
• Enrollment (Actual): 210

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92697
      • University of California, Irvine
    • Stanford, California, United States, 94305
      • Stanford University, Department of Psychiatry and Behavioral Sciences
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Inpatient hospitals, outpatient clinics, community.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Major Depressive Disorder
Healthy Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Genetics	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.	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physiologic	Cortisol hormone levels will be measured in blood (suppression test), hair and saliva samples.	1 year
Neurocognition	Standardized neuropsychological measures will be used to assess neurocognition including, tests involving verbal learning, visual reproduction, attentional flexibility, and memory.	1 year
Clinical	Clinical psychiatric measures will be used to assess depression (HAM-D), psychotic features, suicidality, childhood trauma, and anhedonia.	1 year

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: University of California, Irvine; Cornell University; Pritzker Consortium
• Investigators: Principal Investigator: Alan Schatzberg, M.D., Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2013
• Primary Completion (Actual): August 1, 2020
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: April 9, 2013
• First Submitted That Met QC Criteria: April 10, 2013
• First Posted (Estimate): April 15, 2013

Study Record Updates

• Last Update Posted (Actual): August 21, 2020
• Last Update Submitted That Met QC Criteria: August 19, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 26529