NCT01680107

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2012

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2012

Completed
25 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

May 3, 2018

Status Verified

May 1, 2018

Enrollment Period

5.1 years

First QC Date

September 3, 2012

Last Update Submit

May 2, 2018

Conditions

Keywords

d-cycloserine, cognitive-behaviour therapy, panic disorder

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

EXPERIMENTAL

oral, capsule, 250 mg, once

Drug: d-cycloserineBehavioral: cognitive-behaviour therapy

sugar pill

PLACEBO COMPARATOR

oral, capsule, once

Drug: placeboBehavioral: cognitive-behaviour therapy

Interventions

d-cycloserine
sugar pill
d-cycloserinesugar pill

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Department of Psychiatry, University of Oxford

Oxford, OX37JX, United Kingdom

Location

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.

MeSH Terms

Conditions

Panic Disorder

Interventions

CycloserineCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

IsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsOxazolidinonesOxazolesSerineAmino Acids, NeutralAmino AcidsAmino Acids, Peptides, and ProteinsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Andrea Reinecke, PhD

    University of Oxford

    PRINCIPAL INVESTIGATOR
  • Catherine Harmer, PhD

    University of Oxford

    STUDY DIRECTOR

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

Locations