Exposure, D-Cycloserine Enhancement, and Genetic Modulators in Panic Disorder
Condition: Panic Disorder
MeSH terms: Panic Disorder
Intervention: d-cycloserine; placebo
Intervention description: 50mg; 50mg
Intervention MeSH terms: Cycloserine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 180.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Panic Disorder; Anxiety; D-cycloserine; DCS; Cognitive Behavioral Therapy; CBT

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.
    

Eligibility 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