Identifying Biological Markers for Severe Depression



Status:Completed
Conditions:Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:21 - 70
Updated:4/2/2016
Start Date:July 2013
End Date:April 2016
Contact:Maureen H Chang, B.S.
Email:mhchang@stanford.edu
Phone:650-725-4620

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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.


Inclusion criteria for depressed patients:

1. Diagnostic and Statistical Manuel 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 21 - 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 21 - 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
We found this trial at
3
sites
Irvine, California 92697
949-824-5011
University of California, Irvine Since 1965, the University of California, Irvine has combined the strengths...
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New York, New York 10021
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