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D-cycloserine Augmented CBT for Panic Disorder

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2015 by University of Oxford.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01680107
First Posted: September 6, 2012
Last Update Posted: December 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medical Research Council
Information provided by (Responsible Party):
University of Oxford
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • emotional information processing [ Time Frame: 1 day ]

Estimated Enrollment: 50
Study Start Date: October 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01680107     History of Changes
Other Study ID Numbers: MRC-01
2012-003191-39 ( EudraCT Number )
First Submitted: September 3, 2012
First Posted: September 6, 2012
Last Update Posted: December 3, 2015
Last Verified: November 2015

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

Additional relevant MeSH terms:
Disease
Panic Disorder
Pathologic Processes
Anxiety Disorders
Mental Disorders
Cycloserine
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action