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D-cycloserine Augmented CBT for Panic Disorder

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ClinicalTrials.gov Identifier: NCT01680107
Recruitment Status : Terminated
First Posted : September 6, 2012
Last Update Posted : May 3, 2018
Sponsor:
Collaborator:
Medical Research Council
Information provided by (Responsible Party):
University of Oxford

Brief Summary:
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 or disease Intervention/treatment Phase
Panic Disorder Drug: d-cycloserine Drug: placebo Behavioral: cognitive-behaviour therapy Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
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
Study Start Date : October 2012
Actual Primary Completion Date : October 31, 2017
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Panic Disorder
Drug Information available for: Cycloserine

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. self-reported and clinician-rated anxiety and depression measures [ Time Frame: 6 months ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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

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


Locations
United Kingdom
Department of Psychiatry, University of Oxford
Oxford, United Kingdom, OX37JX
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

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01680107     History of Changes
Other Study ID Numbers: MRC-01
2012-003191-39 ( EudraCT Number )
First Posted: September 6, 2012    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: May 2018

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