Researchers at the Center for Anxiety and Related Disorders at Boston University are conducting a study to evaluate the potential effects of 3 single doses of either an investigational medication or placebo, on the effectiveness of a particular form of psychotherapy (cognitive-behavioral therapy). The medication is investigational because it is not yet FDA approved. It is not designed to reduce anxiety symptoms on its own, but may improve the effectiveness of this type of therapy.
Participation involves the following:
- Completing a screening assessment (interview & medical examination) prior to starting the study and completing some of these assessments throughout the study.
- Attending 5 sessions of cognitive-behavior therapy.
- Taking the medication (or placebo) before 3 of these therapy sessions.
- Returning to the center for 2 follow-up sessions to assess anxiety symptoms.
Individuals who are eligible for the study will receive free cognitive therapy treatment as part of study participation.
Boston University Center for Anxiety and Related Disorders
- Participants must be between the ages of 18 and 55.
- Participants must be fluent in English.
- Participants must be generally healthy.
- Participants must have a primary diagnosis of panic disorder (with or without agoraphobia) as defined by DSM-IV criteria.
- Physical examination, electrocardiogram, and laboratory findings without clinically significant abnormalities.
- Are currently taking no psychotropic medications, are stabilized on anti-depressant and/or anxiolytic medications for 8 weeks prior to the screening visit, or are able and willing to discontinue these medications prior to the screening visit.
- Willingness and ability to comply with the requirements of the study protocol.
- A lifetime history of a psychotic disorder, bipolar disorder, or obsessive-compulsive disorder; an eating disorder in the past 6 months; organic brain syndrome, mental retardation or other cognitive dysfunction that could interfere with capacity to engage in therapy; a history of substance or alcohol abuse or dependence (other than nicotine) in the last 6 months or otherwise unable to commit to refraining from alcohol use during the acute period of study participation.
- Participants with posttraumatic stress disorder within the past 6 months are excluded. Entry of participants with other mood or anxiety disorders will be permitted if the panic disorder is judged to be the predominant disorder.
- Participants with significant suicidal ideation, who have a history of a suicide attempt, or are at significant risk of self-harm or harm to others will be excluded from study participation and referred for appropriate clinical intervention.
- Participants must be off concurrent psychotropic medication (e.g., antidepressants, anxiolytics, beta blockers) for at least 2 weeks prior to initiation of randomized treatment.
- Significant personality dysfunction likely to interfere with study participation.
- Serious medical illness or instability for which hospitalization may be likely within the next year.
- Have a clinically relevant visual disturbance such as cataract, color blindness, macular degeneration, glaucoma, or retinal disease.
- Are receiving concurrent psychotherapy for the treatment of panic disorder [general supportive psychotherapy is acceptable if therapy was initiated at least 3 months prior to the screening visit].
- Are pregnant, planning to become pregnant, or are unwilling to use an acceptable form of birth control during the research study.
Dr. Christen Deveney or Dr. Michael Otto, (617) 358-3891, (617) 358-4307, or firstname.lastname@example.org