D-cycloserine Augmented CBT for Panic Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 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: June 19, 2013
Last verified: June 2013
  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:


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
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.

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 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: June 19, 2013
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 July 26, 2014