NCT00131339

Brief Summary

This study involves cognitive behavioral therapy (CBT) and a medication called D-cycloserine (DCS), which is thought to help reduce panic symptoms more effectively by interacting with N-methyl-D-aspartate (NMDA) glutamate receptors, facilitating many forms of learning including the extinction of fear. Participants will be randomly assigned (like flipping a coin) to receive either DCS or a placebo in addition to CBT.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2004

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2005

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

August 26, 2009

Status Verified

August 1, 2009

First QC Date

August 16, 2005

Last Update Submit

August 25, 2009

Conditions

Panic Disorder

Keywords

panic disordercognitive behavioral therapyD-cycloserinemedicationtreatment trialplacebo-controlleddouble-blindrandomized

Outcome Measures

Primary Outcomes (1)

  • significant reduction in panic symptoms after completion of treatment

Interventions

Cognitive behavioral therapyBEHAVIORAL
D-cycloserineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Principal diagnosis of panic disorder

You may not qualify if:

  • History of psychotic disorders or bipolar disorder
  • Substance dependence
  • Pregnant or breastfeeding
  • History of a medical condition that may increase the risks of taking the study drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

Center for Anxiety and Related Disorders at Boston University

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • Otto MW, Tolin DF, Simon NM, Pearlson GD, Basden S, Meunier SA, Hofmann SG, Eisenmenger K, Krystal JH, Pollack MH. Efficacy of d-cycloserine for enhancing response to cognitive-behavior therapy for panic disorder. Biol Psychiatry. 2010 Feb 15;67(4):365-70. doi: 10.1016/j.biopsych.2009.07.036. Epub 2009 Oct 6.

    PMID: 19811776DERIVED

MeSH Terms

Conditions

Panic Disorder

Interventions

Cognitive Behavioral TherapyCycloserine

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesIsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsOxazolidinonesOxazolesSerineAmino Acids, NeutralAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Michael W. Otto, Ph.D.

    Center for Anxiety and Related Disorders at Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 16, 2005

First Posted

August 18, 2005

Study Start

November 1, 2004

Study Completion

March 1, 2007

Last Updated

August 26, 2009

Record last verified: 2009-08

Locations

US(2)