Identifying Biological Markers for Severe Depression

Major Depressive Disorder Clinical Trial

Official title:

Identifying Biological Markers for Severe Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01831882
• Other study ID #: 26529
• Status: Completed
• Start date: July 2013
• Est. completion date: August 2020

Study information

• Verified date: August 2020
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Locations

Country	Name	City	State
United States	University of California, Irvine	Irvine	California
United States	Weill Cornell Medical College	New York	New York
United States	Stanford University, Department of Psychiatry and Behavioral Sciences	Stanford	California

Sponsors (4)

Lead Sponsor	Collaborator
Stanford University	Cornell University, Pritzker Consortium, University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

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