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Dynamic Measures of Neurochemistry in Mood Disorders

Primary Purpose

Depression

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
sertraline
bupropion
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, antidepressant, SSRI

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Vanderbilt University Medical Center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
April 7, 2017
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00178828
Brief Title
Dynamic Measures of Neurochemistry in Mood Disorders
Official Title
Dynamic Measures of Neurochemistry in Mood Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

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

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, antidepressant, SSRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
sertraline
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
bupropion
Intervention Description
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 Outcome Measure Information:
Title
Power spectral density (PSD) of monoamine metabolite measures
Description
Power spectral density measures the rhythmicity, or periodicity, of the time series of monoamine metabolites.
Time Frame
Before antidepressant treatment and after 4 weeks of antidepressant treatment (during week 5)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald M Salomon, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Dynamic Measures of Neurochemistry in Mood Disorders

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