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Proton MRS Study of SSRI-Zolpidem Interactions

NCT01809626 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2013-03-13

No results posted yet for this study

Summary

The primary goal of this single-blind, placebo-controlled, within-subjects, double-scan, one-visit neuroimaging study is to examine the effects of the hypnotic zolpidem (Ambien®) in individuals who are maintained on selective serotonin reuptake inhibitors (SSRIs) for the treatment of major depressive disorder. Specifically, levels of the brain chemical GABA will be examined in the anterior cingulate and thalamus, two brain regions that play important roles in mediating some of the effects of depression and sleep-related drugs, respectively. Depressed individuals typically have lower levels of GABA than the healthy population, and antidepressant treatment has been shown to help normalize this neurochemical in conjunction with improved mood. Given that individuals maintained on SSRIs often are prescribed sedative/hypnotics to treat concurrent insomnia, understanding a possible neurochemical interaction between them, whether beneficial or harmful, is important for informing evidence-based treatment strategies to treat the co-morbid patient. Zolpidem's effects on GABA in participants who are maintained on SSRIs will be compared to baseline GABA levels in these individuals (i.e., following placebo administration). Two separate scanning sessions lasting approximately 45-60 min each will take place within one single study visit in order to obtain these measurements using proton magnetic resonance spectroscopy (1H MRS). This type of neuroimaging is like an MRI in that it is non-invasive, but it permits us to obtain information about chemicals in the brain. A secondary goal of this study is to compare the subjective drug effects, or how individuals feel, following the intervention. These measures will be used to determine the existence of brain-behavior relationships in order to assess the extent to which modulating GABA with zolpidem has effects on mood states in depressed participants. Collectively, this study will contribute to our understanding of how these drugs exert their effects when one is administered in the presence of the other, and it will demonstrate that imaging is an important tool for informing us about how drug effects in the brain ultimately result in behavior.

Conditions

Interventions

DRUG

Zolpidem

OTHER

Placebo

Sponsors & Collaborators

  • Brain & Behavior Research Foundation

    collaborator OTHER

  • Mclean Hospital

    lead OTHER

Principal Investigators

  • Stephanie C Licata, PhD · Mclean Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2012-09-30
Completion
2012-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01809626 on ClinicalTrials.gov