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Dynamic Measures of Neurochemistry in Mood Disorders

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00178828
First Posted: September 15, 2005
Last Update Posted: April 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Vanderbilt University Medical Center
  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
Intervention Model: Parallel Assignment
Masking: None (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 Medical Center:

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) ]
    Power spectral density measures the rhythmicity, or periodicity, of the time series of monoamine metabolites.


Enrollment: 42
Study Start Date: October 2002
Study Completion Date: April 2013
Primary Completion Date: April 2013 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00178828


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

Additional Information:
Responsible Party: Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00178828     History of Changes
Other Study ID Numbers: 000373
5K23MH001828-03 ( U.S. NIH Grant/Contract )
First Submitted: September 12, 2005
First Posted: September 15, 2005
Last Update Posted: April 11, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vanderbilt University Medical Center:
Depression
antidepressant
SSRI

Additional relevant MeSH terms:
Depression
Mood Disorders
Behavioral Symptoms
Mental Disorders
Bupropion
Sertraline
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Serotonin Uptake Inhibitors
Serotonin Agents