D-cycloserine Augmented CBT for Panic Disorder
Primary Purpose
Panic Disorder
Status
Terminated
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
d-cycloserine
placebo
cognitive-behaviour therapy
Sponsored by
About this trial
This is an interventional basic science trial for Panic Disorder focused on measuring d-cycloserine, cognitive-behaviour therapy, panic disorder
Eligibility 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
Sites / Locations
- Department of Psychiatry, University of Oxford
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
d-cycloserine
sugar pill
Arm Description
oral, capsule, 250 mg, once
oral, capsule, once
Outcomes
Primary Outcome Measures
self-reported and clinician-rated anxiety and depression measures
Secondary Outcome Measures
emotional information processing
Full Information
NCT ID
NCT01680107
First Posted
September 3, 2012
Last Updated
May 2, 2018
Sponsor
University of Oxford
Collaborators
Medical Research Council
1. Study Identification
Unique Protocol Identification Number
NCT01680107
Brief Title
D-cycloserine Augmented CBT for Panic Disorder
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 Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 31, 2017 (Actual)
Study Completion Date
April 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford
Collaborators
Medical Research Council
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Panic Disorder
Keywords
d-cycloserine, cognitive-behaviour therapy, panic disorder
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
d-cycloserine
Arm Type
Experimental
Arm Description
oral, capsule, 250 mg, once
Arm Title
sugar pill
Arm Type
Placebo Comparator
Arm Description
oral, capsule, once
Intervention Type
Drug
Intervention Name(s)
d-cycloserine
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Type
Behavioral
Intervention Name(s)
cognitive-behaviour therapy
Primary Outcome Measure Information:
Title
self-reported and clinician-rated anxiety and depression measures
Time Frame
6 months
Secondary Outcome Measure Information:
Title
emotional information processing
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Reinecke, PhD
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Catherine Harmer, PhD
Organizational Affiliation
University of Oxford
Official's Role
Study Director
Facility Information:
Facility Name
Department of Psychiatry, University of Oxford
City
Oxford
ZIP/Postal Code
OX37JX
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
32229324
Citation
Reinecke A, Nickless A, Browning M, Harmer CJ. Neurocognitive processes in d-cycloserine augmented single-session exposure therapy for anxiety: A randomized placebo-controlled trial. Behav Res Ther. 2020 Jun;129:103607. doi: 10.1016/j.brat.2020.103607. Epub 2020 Mar 19.
Results Reference
derived
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D-cycloserine Augmented CBT for Panic Disorder
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