Exposure, D-Cycloserine Enhancement, and Genetic Modulators in Panic Disorder

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

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 disorder relative to placebo augmentation. By demonstrating that DCS can enhance the results of even a brief treatment strategy, the investigators are seeking to validate an approach that fits well with the practice limitations and applications of CBT in effectiveness studies.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston University; Boston University Charles River Campus
• Collaborators: National Institute of Mental Health (NIMH); National Institute on Drug Abuse (NIDA)
• Treatments: Cycloserine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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