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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00725725
First received: July 28, 2008
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to evaluate the effectiveness of Org 25935 vs. placebo given in combination with cognitive-behavioral therapy to reduce the symptoms of panic disorder.


Condition Intervention Phase
Panic Disorder
Behavioral: Cognitive-behavioral therapy
Drug: Org 25935
Drug: Placebo
Phase 2

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
Official 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Panic Disorder Severity Scale [ Time Frame: Screening, Week 4, End of Treatment, 30-day Follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: July 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 4 mg Org 25935 Behavioral: Cognitive-behavioral therapy
Five weekly sessions of cognitive-behavioral therapy, lasting 60 to 90-min each
Drug: Org 25935
4 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.
Experimental: 12 mg Org 25935 Behavioral: Cognitive-behavioral therapy
Five weekly sessions of cognitive-behavioral therapy, lasting 60 to 90-min each
Drug: Org 25935
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 Comparator: Placebo Behavioral: Cognitive-behavioral therapy
Five weekly sessions of cognitive-behavioral therapy, lasting 60 to 90-min each
Drug: Placebo
Placebo 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Merck Sharp & Dohme Corp.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00725725     History of Changes
Other Study ID Numbers: P05705, 172012
Study First Received: July 28, 2008
Last Updated: September 27, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Panic Disorder
Disease
Anxiety Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014