Dynamic Measures of Neurochemistry in Mood Disorders

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00178828
First received: September 12, 2005
Last updated: March 23, 2011
Last verified: March 2011
  Purpose

The purpose of this study is to understand changes in brain chemical signals when people take antidepressants called sertraline (Zoloft®) and bupropion (Wellbutrin SR, Zyban ®). Spinal fluid is used to measure chemical levels of dopamine, serotonin, and other chemicals thought to be involved in depression. The study has potential to help understand and treat depression.


Condition Intervention Phase
Depression
Drug: sertraline
Drug: bupropion
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dynamic Measures of Neurochemistry in Mood Disorders

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Power spectral density (PSD) of monoamine metabolite measures [ Time Frame: Before antidepressant treatment and after 4 weeks of antidepressant treatment (during week 5) ] [ Designated as safety issue: No ]
    Power spectral density measures the rhythmicity, or periodicity, of the time series of monoamine metabolites.


Enrollment: 42
Study Start Date: October 2002
Estimated Study Completion Date: June 2015
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: sertraline
    Patients will be assigned by random selection to sertraline (50mg daily for one week, then 100mg daily) or bupropion (SR formulation, 150 mg daily for 1 week, then 150 mg BID). A second CSF collection will be completed after 4 weeks of the sertraline treatment (during week 5).
    Drug: bupropion
    Patients will be assigned by random selection to sertraline (50mg daily for one week, then 100mg daily) or bupropion (SR formulation, 150 mg daily for 1 week, then 150 mg BID). A second CSF collection will be completed after 4 weeks of the sertraline treatment (during week 5).
Detailed Description:

The purpose of this study is to understand changes in brain chemical signals when people take antidepressants called sertraline (Zoloft®) and bupropion (Wellbutrin SR, Zyban ®). Spinal fluid is used to measure chemical levels of dopamine, serotonin, and other chemicals thought to be involved in depression. The study has potential to help understand and treat depression.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • AGE RANGE: 18 to 50 years.
  • WEIGHT: within 20% of ideal weight, as specified in the 1983 Metropolitan Height and Weight Tables. Patients who deviate from these ranges may be reviewed on an individual basis by the Investigator. This criterion is necessary because of mechanical risks of poor access in overweight individuals, and because of physiologic risks in underweight individuals.
  • SEX DISTRIBUTION: both men and women (self or partner surgically sterilized, or using double barrier method). To the extent possible, women will have CSF sampling at the same point in their menstrual cycles, ideally during the follicular phase.
  • RACE: any
  • HEALTH: healthy, ambulatory depressed or healthy adults; must show clear capacity to form consent based on a strong understanding of the potential risks and benefits.

Exclusion Criteria:

  • Evidence of significant hepatic, gastrointestinal, renal, respiratory, endocrine, hematologic, neurologic, psychiatric, or cardiovascular system abnormalities, history of deep venous thrombosis (DVT), thrombophlebitis, coagulopathy.
  • Pregnancy.
  • Patients with a known or suspected history of alcohol or drug misuse and/or a positive urine drug screen.
  • Patients who are unwilling or unable to abide by the requirements of the study or who violate the prohibitions and restrictions of the study.
  • Any condition which would make the patient, in the opinion of the Investigator, unsuitable for the study.
  • Patients who have taken any unapproved prior or concomitant medications.
  • Patients who have donated blood within one month of the study.
  • Patients with serious medical illness, history or signs/symptoms of lumbar spine/disc disease or significant laboratory findings.
  • Recent participation in other studies.
  • Patients with histories of migraine will be considered individually, and warned of the risk of headache following spinal tap.
  • Patients who smoke regularly, would experience withdrawal while hospitalized for 5 days, or who cannot abstain from tobacco for the entire duration of the study.
  • Patients who present significant suicide risk, e.g. with a history of highly impulsive suicide attempts.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00178828

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Ronald M Salomon, MD Vanderbilt University
  More Information

Additional Information:
No publications provided

Responsible Party: Ron Salomon, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00178828     History of Changes
Other Study ID Numbers: 000373, 5 K23 MH001828-03
Study First Received: September 12, 2005
Last Updated: March 23, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt University:
Depression
antidepressant
SSRI

Additional relevant MeSH terms:
Depression
Depressive Disorder
Mood Disorders
Behavioral Symptoms
Mental Disorders
Sertraline
Bupropion
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Dopamine Uptake Inhibitors
Dopamine Agents

ClinicalTrials.gov processed this record on July 29, 2014