Proton MRS Study of SSRI-Zolpidem Interactions

NCT01809626 | Completed Early Phase 1

• 1 other identifier: 2009-P-001379
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Change in GABA levels within two specified brain regions (anterior cingulate and thalamus) as measured with proton magnetic resonance spectroscopy

  45 min after drug administration

Secondary Outcomes (1)

• Change in subjective drug effects as measured by self-report questionnaires

  Over the course of 8 hours

Study Arms (2)

Zolpidem (10 mg)

EXPERIMENTAL

Oral administration of the drug zolpidem (Ambien)

Drug: Zolpidem

Gelatin capsule

PLACEBO COMPARATOR

Oral administration of a placebo pill that is packaged identically to the active condition.

Other: Placebo

Interventions

Zolpidem DRUG

Also known as: Ambien

Zolpidem (10 mg)

Placebo OTHER

Gelatin capsule

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mclean Hospital: lead
• Brain & Behavior Research Foundation: collaborator

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Stephanie C Licata, PhD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Psychiatry

Study Record Dates

• First Submitted: March 11, 2013
• First Posted: March 13, 2013
• Study Start: May 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 13, 2013

Record last verified: 2013-03

Locations

US (1)