Clinical trial NCT01831882: Identifying Biological Markers for Severe Depression
Official title: Identifying Biological Markers for Severe Depression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Depressive Disorder
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Cornell University
name: University of California, Irvine
name: Pritzker Consortium
First posted: 2013-04-15
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatient hospitals, outpatient clinics, community.

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.


Eligibility 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

Primary outcomes:
measure: Genetics
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
measure: Physiologic
timeFrame: 1 year
measure: Neurocognition
timeFrame: 1 year
measure: Clinical
timeFrame: 1 year
Locations:
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: Stanford
country: United States
facility: Stanford University, Department of Psychiatry and Behavioral Sciences
state: California
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Stanford University
name: Alan Schatzberg, M.D.
role: PRINCIPAL_INVESTIGATOR
References: