Status:
COMPLETED
Proton MRS Study of SSRI-Zolpidem Interactions
Lead Sponsor:
Mclean Hospital
Collaborating Sponsors:
Brain & Behavior Research Foundation
Conditions:
Depression
Eligibility:
All Genders
21-40 years
Phase:
EARLY_PHASE1
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 ar...
Detailed Description
Sleep disturbances are a primary complaint in at least 35% of depressed patients, and upwards of one third of individuals taking selective serotonin reuptake inhibitors (SSRIs) to treat major depressi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01809626
Start Date
May 1 2010
End Date
December 1 2012
Last Update
March 13 2013
Active Locations (1)
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1
McLean Hospital
Belmont, Massachusetts, United States, 02478