Identifying Biological Markers for Severe Depression

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01831882

Enrollment

210

Registered

2013-04-15

Start date

2013-07-31

Completion date

2020-08-31

Last updated

2020-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Genetics	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

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

Countries

United States

Outcome results