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Completed

NCT Number: NCT00178828

Dynamic Measures of Neurochemistry in Mood Disorders

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sertraline

Drug

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).

bupropion

Drug

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).

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Important dates

Study start
2002
Primary completion
2013
Study completion
2013
First posted
Sep 15, 2005
Registry last updated
Apr 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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