D-cycloserine Augmented CBT for Panic Disorder
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
2 other identifiers
interventional
33
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2012
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 3, 2012
CompletedFirst Posted
Study publicly available on registry
September 6, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2018
CompletedMay 3, 2018
May 1, 2018
5.1 years
September 3, 2012
May 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
self-reported and clinician-rated anxiety and depression measures
6 months
Secondary Outcomes (1)
emotional information processing
1 day
Study Arms (2)
d-cycloserine
EXPERIMENTALoral, capsule, 250 mg, once
sugar pill
PLACEBO COMPARATORoral, capsule, once
Interventions
Eligibility Criteria
You may qualify if:
- clinical diagnosis of panic disorder
- at least moderate agoraphobic avoidance
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oxfordlead
- Medical Research Councilcollaborator
Study Sites (1)
Department of Psychiatry, University of Oxford
Oxford, OX37JX, United Kingdom
Related Publications (1)
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.
PMID: 32229324DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Reinecke, PhD
University of Oxford
- STUDY DIRECTOR
Catherine Harmer, PhD
University of Oxford
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2012
First Posted
September 6, 2012
Study Start
October 1, 2012
Primary Completion
October 31, 2017
Study Completion
April 30, 2018
Last Updated
May 3, 2018
Record last verified: 2018-05