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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
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 3, 2012
Last Updated
May 2, 2018
Sponsor
University of Oxford
Collaborators
Medical Research Council
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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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