Status:
COMPLETED
Exposure, D-Cycloserine Enhancement, and Genetic Modulators in Panic Disorder
Lead Sponsor:
Boston University Charles River Campus
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Conditions:
Panic Disorder
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This is a 5-year double blind, randomized, controlled, trial conducted at three treatment sites, aimed at showing the acute and longer-term effects of DCS augmentation of exposure-based CBT for panic ...
Detailed Description
In this application, the investigators propose to further validate and expand upon one of the apparent striking successes of translational research. Specifically, basic research on the neural circuitr...
Eligibility Criteria
Inclusion
- Male or female outpatients \> 18 years of age with a primary psychiatric diagnosis of panic disorder with or without agoraphobia
- CGI-severity score of 4 or higher
- Physical examination and laboratory findings without clinically significant abnormalities
- Off concurrent psychotropic medication for at least 2 weeks prior to initiation of randomized treatment, OR stable on current medication for a minimum of 6 weeks and willing to maintain a stable dose
- Willingness and ability to comply with the requirements of the study protocol
Exclusion
- Agoraphobia sufficiently severe as to limit patient's ability to travel to and participate in weekly sessions Posttraumatic stress disorder, substance use disorder, eating disorder, or organic mental disorder within the past 6 months
- Lifetime history of psychotic disorder, bipolar disorder, or developmental disorder
- Significant suicidal ideation or suicidal behaviors within the past 6 months
- Significant personality dysfunction likely to interfere with study participation
- Serious medical illness or instability for which hospitalization may be likely within the next year
- Patients with a current or past history of seizures (other than febrile seizures in childhood)
- Pregnant women, lactating women, and women of childbearing potential who are not using medically accepted forms of contraception
- Concurrent psychotherapy initiated within 3 months of baseline, or ongoing psychotherapy of any duration directed specifically toward treatment of the panic disorder other than general supportive therapy initiated at least 3 months prior to study
- Prior adequate trial of CBT for panic disorder
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00790868
Start Date
April 1 2008
End Date
August 1 2014
Last Update
March 7 2018
Active Locations (4)
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1
Institute of Living
Hartford, Connecticut, United States, 06106
2
Rush University Medical Center
Chicago, Illinois, United States, 60612
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
4
Boston University
Boston, Massachusetts, United States, 02215