Dynamic Measures of Neurochemistry in Mood Disorders
This study is ongoing, but not recruiting participants.
Sponsor:
Vanderbilt University
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00178828
First received: September 12, 2005
Last updated: March 23, 2011
Last verified: March 2011
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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:
Drug Information available for:
Bupropion hydrochloride
Bupropion
Sertraline hydrochloride
Sertraline
U.S. FDA Resources
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:
Detailed Description:
-
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).
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
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 May 23, 2013