Identifying Biological Markers for Severe Depression

NCT ID: NCT01831882

Last Updated: 2020-08-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 210 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2020-08-31

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.

Conditions

Major Depressive Disorder

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Major Depressive Disorder

No interventions assigned to this group

Healthy Control

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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.

1. Between 18 - 70 years of age.

2. Have a HAM-D score of less than or equal to 5.

Exclusion Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cornell University

OTHER

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: collaborator

Pritzker Consortium

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Alan Schatzberg

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alan Schatzberg, M.D.

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

University of California, Irvine

Irvine, California, United States

Stanford University, Department of Psychiatry and Behavioral Sciences

Stanford, California, United States

Weill Cornell Medical College

New York, New York, United States

Countries

United States

Other Identifiers

26529

Identifier Type: -

Identifier Source: org_study_id