Identifying Biological Markers for Severe Depression | NCT01831882

Studies
Identifying Biological Markers for Severe Depression

NCT01831882

Sponsor

Stanford University

Status

Completed

Last Update Posted

Aug 21, 2020Actual

Enrollment

210Actual

Phase

Not provided

Conditions

Major Depressive Disorder

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013Actual

Primary Completion Date

Aug 2020Actual

Completion Date

Aug 2020Actual

First Submitted Date

Apr 9, 2013

First Submission Date that Met QC Criteria

Apr 10, 2013

First Posted Date

Apr 15, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2020

Last Update Posted Date

Aug 21, 2020Actual

Name	Class
Cornell University	OTHER
University of California, Irvine	OTHER
Pritzker Consortium	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

210Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

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.

Eligibility Module

Eligibility Criteria

Inclusion criteria for depressed patients:

Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) diagnosis of Unipolar Major Depressive Disorder with or without psychotic features.
21-item Hamilton Depression Rating Scale (HDRS) score greater than or equal to 21.
Thase Core Endogenomorphic Scale score greater than or equal to 8 on the items included in the 21-item HDRS.
Between 18 - 70 years of age.
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.
Pre-existing (current) primary treating psychiatrist for subjects with psychotic features.
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:

Between 18 - 70 years of age.
Have a HAM-D score of less than or equal to 5.

Exclusion Criteria for depressed patients:

Electroconvulsive Therapy (ECT) in the 6 months prior to the study.
Abuse of drugs or alcohol in the 6 months prior to study.
Unstable or untreated hypertension or cardiovascular disease.
Use of additional prescription medications, street drugs, or alcohol during the week before the study.
Any Axis II diagnosis or traits which would make participation in the study difficult.
Current pregnancy or lactation.
Post-partum depression
Diagnosis of obsessive-compulsive disorder
History of significant cognitive decline

Exclusion criteria for healthy controls:

Personal history of Axis I or Axis II disorders.
Active unstable medical problems.
Abuse of drugs or alcohol in the 6 months prior to study.
Use of additional prescription medications, street drugs, or alcohol during the week before the study.
Currently pregnant or lactating.
History of significant cognitive decline

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Inpatient hospitals, outpatient clinics, community.

Sampling Method

Non-Probability Sample

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders

Facility	Status	City	State	ZIP	Country	Contacts
University of California, Irvine		Irvine	California	92697	United States
Stanford University, Department of Psychiatry and Behavioral Sciences