D-cycloserine Augmented CBT for Panic Disorder

NCT ID: NCT01680107

Last Updated: 2018-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2018-04-30

Brief Summary

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The purpose of this study is to determine whether d-cycloserine augments the clinical effects of exposure-based cognitive-behaviour therapy for panic disorder.

Detailed Description

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Conditions

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Panic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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d-cycloserine

oral, capsule, 250 mg, once

Group Type EXPERIMENTAL

d-cycloserine

Intervention Type DRUG

cognitive-behaviour therapy

Intervention Type BEHAVIORAL

sugar pill

oral, capsule, once

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

cognitive-behaviour therapy

Intervention Type BEHAVIORAL

Interventions

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d-cycloserine

Intervention Type DRUG

placebo

Intervention Type DRUG

cognitive-behaviour therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical Research Council

OTHER_GOV

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrea Reinecke, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Catherine Harmer, PhD

Role: STUDY_DIRECTOR

University of Oxford

Locations

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Department of Psychiatry, University of Oxford

Oxford, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 32229324 (View on PubMed)

Other Identifiers

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2012-003191-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MRC-01

Identifier Type: -

Identifier Source: org_study_id

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