Org 25935 Versus Placebo as Augmentation to Cognitive-behavioral Therapy to Treat Panic Disorder (P05705AM3)(TERMINATED)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00725725
• Date of registration: 28/07/2008
• Primary sponsor: Schering-Plough
• Public title: Org 25935 Versus Placebo as Augmentation to Cognitive-behavioral Therapy to Treat Panic Disorder (P05705AM3)(TERMINATED)
• Scientific title: 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
• Date of first enrolment: July 2008
• Target sample size: 60
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00725725
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

United States

Key inclusion & exclusion 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 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 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. Subjects 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 CSSRS. Subjects 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 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Panic Disorder

Intervention(s)

Behavioral: Cognitive-behavioral therapy

Drug: Org 25935

Drug: Placebo

Primary Outcome(s)

Panic Disorder Severity Scale [Time Frame: Screening, Week 4, End of Treatment, 30-day Follow-up]

Secondary Outcome(s)

Clinical Global Impression Scale - Severity; Hamilton Anxiety Rating Scale - Structured Interview; Anxiety Sensitivity Index; Montgomery Asberg Depression Rating Scale; Quality of Life Enjoyment and Satisfaction Questionnaire [Time Frame: Weekly visits are required, secondary efficacy is measured at Screening, End of Treatment, and at the 30-day Follow-up Visit.]

Safety and tolerability [Time Frame: Safety and tolerability is assessed at Screening, End of Treatment, and depending on measure, at regular intervals during the trial.]

Secondary ID(s)

172012

P05705

Source(s) of Monetary Support

Please refer to primary and secondary sponsors