Org 25935 Versus Placebo as Augmentation to Cognitive-behavioral Therapy to Treat Panic Disorder (P05705)

NCT00725725 | Terminated Phase 2 Results

• 3 other identifiers: P05705MK-8435-002Org 172012
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Panic Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Panic Disorder Severity Scale (PDSS) Score From Baseline to End-of-Treatment (EOT)

  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).

  Screening and Day 36

Secondary Outcomes (11)

• Change in PDSS Score From Baseline to Visit 4

  Screening and Visit 4 (Day 22)

• Change in PDSS Score From Baseline to Follow-Up

  Screening and Follow-Up (Day 59)

• 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

• SCID-I/P With Psy Screen Score at EOT

  Day 36

• Change in Clinical Global Impression-Severity (CGI-S) Score

  Screening and Day 36

Study Arms (3)

4 mg Org 25935

EXPERIMENTAL

Participants took a total of 3 doses of 4 mg Org 25935 prior to therapy sessions over a 2-week period.

Behavioral: Cognitive-behavioral therapy; Drug: Org 25935

12 mg Org 25935

EXPERIMENTAL

Participants took a total of 3 doses of 12 mg Org 25935 prior to therapy sessions over a 2-week period.

Behavioral: Cognitive-behavioral therapy; Drug: Org 25935

Placebo

PLACEBO COMPARATOR

Participants took a total of 3 doses of placebo matched to Org 25935 prior to therapy sessions over a 2-week period.

Behavioral: Cognitive-behavioral therapy; Drug: Placebo

Interventions

Cognitive-behavioral therapy BEHAVIORAL

Participants underwent 5 weekly CBT session (sessions were 60-90 minutes in duration).

12 mg Org 25935; 4 mg Org 25935; Placebo

Org 25935 DRUG

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.

4 mg Org 25935

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Nations KR, Smits JA, Tolin DF, Rothbaum BO, Hofmann SG, Tart CD, Lee A, Schipper J, Sjogren M, Xue D, Szegedi A, Otto MW. Evaluation of the glycine transporter inhibitor Org 25935 as augmentation to cognitive-behavioral therapy for panic disorder: a multicenter, randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2012 May;73(5):647-53. doi: 10.4088/JCP.11m07081. Epub 2012 Feb 21.

  PMID: 22394471 DERIVED

MeSH Terms

Conditions

Panic Disorder

Interventions

Cognitive Behavioral Therapy; N-methyl-N-(6-methoxy-1-phenyl-1,2,3,4-tetrahydronaphthalen-2-ylmethyl)aminomethylcarboxylic acid

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Senior Vice President, Global Clinical Develpment
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2008
• First Posted: July 30, 2008
• Study Start: July 23, 2008
• Primary Completion: April 23, 2010
• Study Completion: April 23, 2010
• Last Updated: October 16, 2018
• Results First Posted: December 30, 2016

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share