NCT01831882

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2013

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 15, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

August 21, 2020

Status Verified

August 1, 2020

Enrollment Period

7.1 years

First QC Date

April 9, 2013

Last Update Submit

August 19, 2020

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • 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

Other Outcomes (3)

  • Physiologic

    1 year

  • Neurocognition

    1 year

  • Clinical

    1 year

Study Arms (2)

Major Depressive Disorder

Healthy Control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inpatient hospitals, outpatient clinics, community.

You may qualify if:

  • Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV) diagnosis of Unipolar Major Depressive Disorder with or without psychotic features.
  • 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.

You may not qualify if:

  • Between 18 - 70 years of age.
  • Have a HAM-D score of less than or equal to 5.
  • 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
  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of California, Irvine

Irvine, California, 92697, United States

Location

Stanford University, Department of Psychiatry and Behavioral Sciences

Stanford, California, 94305, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

We will be retaining biospecimens including, whole blood, serum, hair and saliva tissues samples.

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Alan Schatzberg, M.D.

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

April 9, 2013

First Posted

April 15, 2013

Study Start

July 1, 2013

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

August 21, 2020

Record last verified: 2020-08

Locations

US(3)