Dynamic Measures of Neurochemistry in Mood Disorders

Depression Clinical Trial

Official title:

Dynamic Measures of Neurochemistry in Mood Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00178828
• Other study ID #: 000373
• Secondary ID: 5K23MH001828-03
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2005
• Last updated: April 7, 2017
• Start date: October 2002
• Est. completion date: April 2013

Study information

• Verified date: April 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Mood Disorders

Intervention

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).
• 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).

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Power spectral density (PSD) of monoamine metabolite measures	Power spectral density measures the rhythmicity, or periodicity, of the time series of monoamine metabolites.	Before antidepressant treatment and after 4 weeks of antidepressant treatment (during week 5)

External Links

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