Exposure, D-Cycloserine Enhancement, and Genetic Modulators in Panic Disorder

NCT00790868 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: R01MH081116
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 4

Brief Summary

This is a 5-year double blind, randomized, controlled, trial conducted at three treatment sites, aimed at showing the acute and longer-term effects of DCS augmentation of exposure-based CBT for panic disorder relative to placebo augmentation. By demonstrating that DCS can enhance the results of even a brief treatment strategy, the investigators are seeking to validate an approach that fits well with the practice limitations and applications of CBT in effectiveness studies.

Conditions

Panic Disorder

Keywords

Panic Disorder; Anxiety; D-cycloserine; DCS; Cognitive Behavioral Therapy; CBT

Outcome Measures

Primary Outcomes (2)

• Panic Disorder Severity Scale (PDSS)

  The percent change in PDSS score from baseline to the relevant assessment points is the continuous primary outcome measure. The PDSS consists of seven items, each rated on a 0 to 4 scale (0 denoting none, and higher ratings reflecting greater degrees of symptom severity; for a possible range in scores from 0 to 28). In the tabular data below we present the total scores (sum of items).

  baseline, mid-TX, post-TX, follow-up visits 1-4

• Remission Status

  Remission status will be used as the primary categorical outcome variable. The CGI-S was used in determining whether patients met the "CGI-S of 1 or 2" component of the "remission status" criteria (i.e., zero panic attacks and CGI-S of 1 or 2 at endpoint). No values are missing because remission must be confirmed; missing status is assigned to disorder status. Hence results are for the full randomized sample.

  Pre-treatment, Post-Treatment, and each follow-up sessions

Secondary Outcomes (3)

• Depression Severity

  Baseline, Tx Endpoint, Each of 4 follow-up assessments

• Quality of Life Ratings

  Baseline, Tx Endpoint, Each of 4 follow-up assessments

• Role Functioning

  Baseline, Tx Endpoint, Each of 4 follow-up assessments

Study Arms (2)

D-cycloserine

EXPERIMENTAL

DCS-augmented CBT

Drug: d-cycloserine

Placebo

PLACEBO COMPARATOR

placebo-augmented CBT

Drug: placebo

Interventions

d-cycloserine DRUG

50mg

Also known as: DCS

D-cycloserine

placebo DRUG

50mg

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female outpatients \> 18 years of age with a primary psychiatric diagnosis of panic disorder with or without agoraphobia
• CGI-severity score of 4 or higher
• Physical examination and laboratory findings without clinically significant abnormalities
• Off concurrent psychotropic medication for at least 2 weeks prior to initiation of randomized treatment, OR stable on current medication for a minimum of 6 weeks and willing to maintain a stable dose
• Willingness and ability to comply with the requirements of the study protocol

You may not qualify if:

• Agoraphobia sufficiently severe as to limit patient's ability to travel to and participate in weekly sessions Posttraumatic stress disorder, substance use disorder, eating disorder, or organic mental disorder within the past 6 months
• Lifetime history of psychotic disorder, bipolar disorder, or developmental disorder
• Significant suicidal ideation or suicidal behaviors within the past 6 months
• Significant personality dysfunction likely to interfere with study participation
• Serious medical illness or instability for which hospitalization may be likely within the next year
• Patients with a current or past history of seizures (other than febrile seizures in childhood)
• Pregnant women, lactating women, and women of childbearing potential who are not using medically accepted forms of contraception
• Concurrent psychotherapy initiated within 3 months of baseline, or ongoing psychotherapy of any duration directed specifically toward treatment of the panic disorder other than general supportive therapy initiated at least 3 months prior to study
• Prior adequate trial of CBT for panic disorder

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• National Institute on Drug Abuse (NIDA): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (4)

Institute of Living

Hartford, Connecticut, 06106, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Boston University

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Otto MW, Pollack MH, Dowd SM, Hofmann SG, Pearlson G, Szuhany KL, Gueorguieva R, Krystal JH, Simon NM, Tolin DF. RANDOMIZED TRIAL OF D-CYCLOSERINE ENHANCEMENT OF COGNITIVE-BEHAVIORAL THERAPY FOR PANIC DISORDER. Depress Anxiety. 2016 Aug;33(8):737-45. doi: 10.1002/da.22531. Epub 2016 Jun 17.

  PMID: 27315514 RESULT

MeSH Terms

Conditions

Panic Disorder; Anxiety Disorders

Interventions

Cycloserine

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

The investigators did not systematically collect fear estimates across exposure and are therefore unable to examine this factor as a moderator. Unexpected site effects were observed for several of our outcome variables.

Results Point of Contact

• Title: Michael W. Otto, Ph.D.
• Organization: BostonUCRC

mwotto@bu.edu

(617)353-9610

Study Officials

• Michael W Otto, PhD

  Boston University

  STUDY CHAIR

• David F Tolin, PhD

  Institute of Living

  PRINCIPAL INVESTIGATOR

• Mark H Pollack, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: November 13, 2008
• First Posted: November 14, 2008
• Study Start: April 1, 2008
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: March 7, 2018
• Results First Posted: March 7, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)