A Multi-center, Double-blind, Fixed Dose Trial Examining the Efficacy and Safety of Org 25935 Versus Placebo as Augmentation to Cognitive Behavioral Therapy in Subjects With Panic Disorder
Overview
- Phase
- Phase 2
- Intervention
- Cognitive-behavioral therapy
- Conditions
- Panic Disorder
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 46
- Primary Endpoint
- Change in Panic Disorder Severity Scale (PDSS) Score From Baseline to End-of-Treatment (EOT)
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief 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.
Investigators
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);
Arms & Interventions
4 mg Org 25935
Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
Intervention: Cognitive-behavioral therapy
4 mg Org 25935
Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.
Intervention: Org 25935
12 mg Org 25935
Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
Intervention: Cognitive-behavioral therapy
12 mg Org 25935
Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.
Intervention: Org 25935
Placebo
Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
Intervention: Cognitive-behavioral therapy
Placebo
Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.
Intervention: Placebo
Outcomes
Primary Outcomes
Change in Panic Disorder Severity Scale (PDSS) Score From Baseline to End-of-Treatment (EOT)
Time Frame: Screening and Day 36
The mean change in PDSS score from baseline (Screening) to EOT (Day 36) was calculated for each arm. The PDSS is a 7-item clinician-rated scale that assesses multiple dimensions of panic disorder severity (e.g., frequency of panic attacks). Each item is scored on a 5-point Likert scale (0 to 4) with the total score ranging from a minimum of 0 to a maximum of 28 (higher scores indicate greater panic disorder severity).
Secondary Outcomes
- SCID-I/P With Psy Screen Score at EOT(Day 36)
- Change in Anxiety Sensitivity Index (ASI) Score(Screening and Day 36)
- Number of Participants Discontinuing Study Therapy Due to AEs(Up to 2 weeks)
- Change in Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) Score(Screening and Day 36)
- Change in PDSS Score From Baseline to Visit 4(Screening and Visit 4 (Day 22))
- Structured Clinical Interview for DSM-IV-TR Axis 1 Disorders, Patient Edition With Psychotic Screen (SCID-I/P With Psy Screen) Score at Screening(Screening)
- Change in Clinical Global Impression-Severity (CGI-S) Score(Screening and Day 36)
- Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score(Screening and Day 36)
- Number of Participants Experiencing an Adverse Event (AE)(Up to 59 days)
- Change in PDSS Score From Baseline to Follow-Up(Screening and Follow-Up (Day 59))
- Change in Montgomery-Asberg Rating Scale for Depression (MADRS) Score(Screening and Day 36)