Brain, Biology and Mood Study

This study is currently recruiting participants.
Verified April 2014 by University of California, San Francisco
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00285935
First received: January 31, 2006
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

The purpose of the Brain, Biology and Mood study is to examine the association between stress, depression and cell death in the hippocampus. We fully expect this study to highlight components of a "stress vulnerability pathway" that will be amenable to new pharmaceutical development and to improved diagnostic methods for patients with major depression. The centerpiece of this program is a prospective study comparing unmedicated depressed patients with matched healthy controls at baseline.


Condition
Major Depressive Disorder

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Neurosteroid Metabolism and the Antidepressant Effects of Serotonin Specific Reuptake Inhibitors (SSRI's)

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Depression ratings at baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Anxiety ratings at baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Serum levels of steroids and neurosteroids at baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum levels of oxidative stress markers at baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Serum levels of cytokines and immune markers at baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • Peripheral blood mononuclear cell telomere length and telomerase levels at baseline [ Time Frame: baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 164
Study Start Date: December 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Detailed Description:

Following an initial telephone screen to assess inclusion and exclusion criteria, the evaluation will continue with an in-person evaluation to assess the presence or absence of active medical history and history of major psychiatric illness, as well as review of the consent document. Eligible, consenting healthy control and depressed subjects will complete a urine screening test for drugs of abuse (and pregnancy for women of child-bearing capacity), psychological tests measuring mood and memory, have a blood draw of approximately 190 cc, and be given materials and instructions for home saliva and urine collection.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Healthy Controls Depressed subjects

Criteria

Inclusion Criteria:

  • English speaking (to allow accurate use of the behavioral rating scales and verbal cognitive tests)
  • Females of child-bearing capacity must be non-pregnant (confirmed by urine pregnancy test) and using effective non-hormonal birth control (e.g. abstinence, condoms, IUD)
  • Age 18-70 y.o.
  • Good general medical health; no active significant uncontrolled medical illness.
  • Clinical labs (electrolytes, liver function test, CBC) with no clinically significant abnormalities
  • Negative urine toxicology (drugs of abuse) screen.
  • Taking no medication or drugs likely to interfere with the study objectives (including birth control pills and corticosteroids), except as allowed by protocol
  • Free of any antidepressant, mood-stabilizing or anti-anxiety medication for a minimum of 6 weeks before entry into the study (with the exception of prn benzodiazepine, anxiolytic or sedative-hypnotic use, < 3 nights per week)
  • BMI ≤ 38 and able to fit comfortably in the MRI/MRSI scanner
  • Able to give informed consent
  • Current DSM-IV Axis I diagnosis of Major Depressive Disorder, unipolar, without psychotic features (co-morbid diagnoses of Panic, Generalized Anxiety Disorder, or Phobias are permitted).
  • Baseline 17-item Hamilton Depression Rating Scale (HDRS) rating of > 17
  • Baseline HDRS item #3 ("suicidality") rating of < 1, and clinician's determination of absence of active suicidal intent.
  • No anticipated changes in psychotherapeutic interventions during the course of the study.

Exclusion Criteria:

  • No recent (< 6 month) history of substance or alcohol abuse (DSM-IV criteria)
  • No current diagnosis of Post-Traumatic Stress Disorder
  • Not "needle phobic," by self-report
  • Not "claustrophobic" by self-report
  • No metal implants
  • No significant neurological diseases such as schizophrenia, mental retardation, and significant head injury
  • No electroconvulsive therapy (ECT) within the past 6 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00285935

Contacts
Contact: Owen Wolkowitz, MD 415-476-7433 Owen.Wolkowitz@ucsf.edu

Locations
United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94143-0984
Contact: Owen Wolkowitz, MD    415-476-7433    Owen.Wolkowitz@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Owen Wolkowitz, MD University of California, San Francisco
  More Information

No publications provided by University of California, San Francisco

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00285935     History of Changes
Other Study ID Numbers: 10-00825
Study First Received: January 31, 2006
Last Updated: April 9, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on April 16, 2014