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Trial record 11 of 120 for:    zolpidem AND Hypnotics

Proton MRS Study of SSRI-Zolpidem Interactions

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ClinicalTrials.gov Identifier: NCT01809626
Recruitment Status : Completed
First Posted : March 13, 2013
Last Update Posted : March 13, 2013
Sponsor:
Collaborator:
Brain & Behavior Research Foundation
Information provided by (Responsible Party):
Stephanie C. Licata, Ph.D., Mclean Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Depression Drug: Zolpidem Other: Placebo Early Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Proton MRS Study of SSRI-Zolpidem Interactions
Study Start Date : May 2010
Actual Primary Completion Date : September 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Zolpidem (10 mg)
Oral administration of the drug zolpidem (Ambien)
Drug: Zolpidem
Other Name: Ambien

Placebo Comparator: Gelatin capsule
Oral administration of a placebo pill that is packaged identically to the active condition.
Other: Placebo



Primary Outcome Measures :
  1. Change in GABA levels within two specified brain regions (anterior cingulate and thalamus) as measured with proton magnetic resonance spectroscopy [ Time Frame: 45 min after drug administration ]

Secondary Outcome Measures :
  1. Change in subjective drug effects as measured by self-report questionnaires [ Time Frame: Over the course of 8 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Participant Eligibility Criteria

  • Participants will be male and female volunteers between the ages of 21-40 recruited via newspaper advertisements and web-based bulletin boards
  • Participants will meet DSM-IV criteria for major depressive disorder, but they cannot meet criteria for any other major psychiatric disorders
  • With the exception of certain short-term anti fungal agents, some topical creams for dermal conditions, and birth control pills, participants cannot be taking any prescription medication other than stable (i.e., ≥ 3 weeks) fluoxetine (≤ 40 mg/day; Prozac), sertraline (≤ 100 mg/day; Zoloft), citalopram (≤ 40 mg/day; Celexa), or paroxetine (≤ 40 mg/day; Paxil)
  • Non-smoking participants are preferred, but will admit those who smoke less than 5 cigarettes per day
  • Participants cannot have a history of major head trauma resulting in cognitive impairment.
  • Participants cannot have any conditions that are contraindicated for MRI
  • Participants cannot have any abnormal blood chemistries or urinalysis results or any current or history of cardiac problems

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01809626


Locations
United States, Massachusetts
McLean Hospital
Belmont, Massachusetts, United States, 02478
Sponsors and Collaborators
Mclean Hospital
Brain & Behavior Research Foundation
Investigators
Principal Investigator: Stephanie C Licata, PhD Mclean Hospital

Responsible Party: Stephanie C. Licata, Ph.D., Assistant Professor, Department of Psychiatry, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01809626     History of Changes
Other Study ID Numbers: 2009-P-001379
First Posted: March 13, 2013    Key Record Dates
Last Update Posted: March 13, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Zolpidem
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action