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D-cycloserine Augmented CBT for Panic Disorder

This study is not yet open for participant recruitment.
Verified September 2012 by University of Oxford
Sponsor:
Collaborator:
Medical Research Council
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01680107
First received: September 3, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
  Purpose

The purpose of this study is to determine whether d-cycloserine augments the clinical effects of exposure-based cognitive-behaviour therapy for panic disorder.


Condition Intervention Phase
Panic Disorder
 Drug: d-cycloserine
Drug: placebo
Behavioral: cognitive-behaviour therapy
 Phase 3

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: Basic Science
Official Title: The Effect of a Single-dose of D-cycloserine on the Basic Effects of Cognitive-behaviour Therapy for Panic Disorder - a Randomized Placebo-controlled Trial

Resource links provided by NLM:

Drug Information available for: Cycloserine
U.S. FDA Resources

Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • self-reported and clinician-rated anxiety and depression measures [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • emotional information processing [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: d-cycloserine
oral, capsule, 250 mg, once
 Drug: d-cycloserine Behavioral: cognitive-behaviour therapy
Placebo Comparator: sugar pill
oral, capsule, once
 Drug: placebo Behavioral: cognitive-behaviour therapy

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinical diagnosis of panic disorder
  • at least moderate agoraphobic avoidance

Exclusion Criteria:

  • psychoactive medication last 6 weeks
  • exposure-based cognitive-behaviour treatment for panic disorder and agoraphobia during last 3 months
  • female participant who is pregnant or breast-feeding
  • lifetime history of psychosis, bipolar disorder, alcohol, medication or drug abuse or dependence; current primary depressive disorder
  • lifetime history of epilepsy or other significant disease or disorder
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01680107

Contacts
Contact: Andrea Reinecke, PhD +44 (0)1865 226471 andrea.reinecke@psych.ox.ac.uk

Locations
United Kingdom
Department of Psychiatry, University of Oxford Not yet recruiting
Oxford, United Kingdom, OX37JX
Contact: Andrea Reinecke, PhD     +44 (0)1865 226471     andrea.reinecke@psych.ox.ac.uk    
Principal Investigator: Andrea Reinecke, PhD            
Sponsors and Collaborators
University of Oxford
Medical Research Council
Investigators
Principal Investigator: Andrea Reinecke, PhD University of Oxford
Study Director: Catherine Harmer, PhD University of Oxford
  More Information

No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01680107     History of Changes
Other Study ID Numbers: MRC-01, 2012-003191-39
Study First Received: September 3, 2012
Last Updated: September 3, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Oxford:
d-cycloserine, cognitive-behaviour therapy, panic disorder

Additional relevant MeSH terms:
Panic Disorder
Anxiety Disorders
Mental Disorders
Cycloserine
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
 Pharmacologic Actions
Renal Agents
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013