Org 25935 Versus Placebo as Augmentation to Cognitive-behavioral Therapy to Treat Panic Disorder (P05705)
Condition: Panic Disorder
MeSH terms: Panic Disorder
Intervention: Cognitive-behavioral therapy; Org 25935; Org 25935; Placebo
Intervention description: Participants underwent 5 weekly CBT session (sessions were 60-90 minutes in duration).; 4 mg Org 25935 is given in tablet form, a single dose 2 hours prior to 3 CBT sessions. A total of 3 doses of trial medication is given over a 2-week period.; 12 mg Org 25935 is given in tablet form, a single dose two hours prior to 3 CBT sessions. A total of 3 doses of trial medication is given over a two-week period.; Placebo is given in tablet form, a single dose 2 hours prior to 3 CBT sessions. A total of 3 doses of trial medication is given over a 2-week period.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effectiveness of Org 25935 vs. placebo given in
      combination with cognitive-behavioral therapy (CBT) to reduce the symptoms of panic disorder.
      It is hypothesized that treatment with Org 25935 at a dose of 4 mg or 12 mg will differ
      significantly from placebo with respect to the Panic Disorder Severity Scale (PDSS) total
      score over 3 weeks of therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  is a male, or a female who is not of childbearing potential or who is non-pregnant,
             non-lactating and using a medically accepted method of contraception.

          -  is between the ages of 18 and 65, inclusive;

          -  signed written informed consent after the scope and nature of the investigation have
             been explained to them before Screening evaluations;

          -  is fluent in English;

          -  is diagnosed at Screening with current panic disorder, with or without agoraphobia;

          -  has a Clinical Global Impressions (CGI)-Severity score at Screening of >= 4 and <= 6;

          -  is currently taking no psychotropic medications or is able and willing to discontinue
             these medications prior to the first CBT session. Anti-depressant and anxiolytic
             medications are acceptable only if they are stabilized for at least 8 weeks prior to
             Screening;

          -  is able to complete all scheduled assessment and treatment visits and is willing to
             comply with the requirements of the study protocol.

        Exclusion Criteria:

          -  is diagnosed with a primary Axis I disorder other than panic disorder;

          -  has a Screening Montgomery-Asberg Depression Rating Scale (MADRS) score of >= 35
             (severe depression);

          -  has any history of bipolar disorder, psychotic disorder, or obsessive compulsive
             disorder;

          -  has a diagnosis of post traumatic stress disorder, eating disorder, or substance abuse
             or dependence (excluding nicotine) within the past six months;

          -  is known or suspected to have significant personality dysfunction that could, in the
             investigator's opinion, interfere with trial participation. Participants with known
             borderline or avoidant personality disorder are excluded;

          -  are at imminent risk of self-harm or harm to others, in the investigator's opinion
             based on clinical interview and responses provided on the Columbia Suicide Severity
             Rating Scale (C-SSRS). Participants must be excluded if they report suicidal ideation
             of Type 4 or 5 in the past 3 months or suicidal behavior in the past 12 months as
             measured by the C-SSRS at Screening;

          -  is currently a psychiatric inpatient or has been hospitalized for a psychiatric
             condition within the past year;

          -  has ever been diagnosed with organic brain syndrome, mental retardation, or other
             cognitive dysfunction that could interfere with their capacity to participate in CBT
             or to complete safety and efficacy assessments;

          -  has any history of head trauma causing ongoing cognitive impairment;

          -  has any history of seizures (apart from childhood febrile seizures);

          -  has an uncontrolled, unstable clinically significant medical condition (e.g., renal,
             endocrine, hepatic, respiratory, cardiovascular, hematologic, immunologic or
             cerebrovascular disease, or malignancy) that may interfere with the interpretation of
             safety and efficacy evaluations in the opinion of the investigator;

          -  has a clinically relevant visual disturbance, such as cataract, color blindness,
             macular degeneration, glaucoma, or retinal disease;

          -  has clinically significant abnormal laboratory, vital sign, physical examination, or
             electrocardiogram (ECG) findings at Screening that may interfere with the
             interpretation of safety or efficacy assessments in the opinion of the investigator;

          -  has a Corrected QT interval (QTc) value >450 milliseconds at Screening using Bazett's
             QTc formula;

          -  for females, has a positive result on serum pregnancy test (at Screening), or plan to
             become pregnant during the course of the trial;

          -  has a positive urine drug or alcohol breath test at Screening, unless the positive
             finding can be accounted for by documented prescription use;

          -  is unable or unwilling to comply with the investigator's instructions regarding drug
             and alcohol use during the trial period;

          -  has a history of sensitivity/idiosyncrasy to glutamatergic drugs or chemically related
             compounds or excipients which may be employed in the trial or to any other unknown
             drug used in the past;

          -  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 Screening] or have received a prior adequate trial of CBT for panic disorder;

          -  has been exposed to an investigational drug within 6 months prior to Screening.