Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000351516
Ethics application status
Approved
Date submitted
28/07/2006
Date registered
16/08/2006
Date last updated
16/08/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
The role of D-Cycloserine in combination with exposure therapy in the treatment of Panic Disorder to improve the severity of panic symptoms.
Scientific title
A randomised controlled trial to evaluate the effects of D-Cycloserine in combination with Exposure Therapy in the treatment of panic disorder to improve the severity of Panic Symptoms
Secondary ID [1] 289 0
Human Research Ethics Committee (HREC): HREC 04145
Secondary ID [2] 290 0
Clinical Trial Notification (CTN): 2004/443
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Panic Disorder 1321 0
Condition category
Condition code
Mental Health 1408 1408 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
D-Cycloserine and Exposure Therapy. Participants are given 3 weekly sessions (once per week) of group-based exposure therapy. One group of participants receives D-Cycloserine (50mg) before each therapy session. Each dose is given orally in capsule form once before each of the three therapy sessions.
Intervention code [1] 1232 0
Treatment: Drugs
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 1929 0
Severity of Panic Symptoms
Timepoint [1] 1929 0
Assessed immeidately after the three week intervention, one month and three months post intervention dated from the end of the three weeks of therapy.
Secondary outcome [1] 3390 0
Global functioning such as their general health, depression and stress levels and current diagnosis.
Timepoint [1] 3390 0
Assessed immediately after the three week intervention and one month and three months post intervention dated from the end of the three weeks of therapy.

Eligibility
Key inclusion criteria
Primary diagnosis of Panic Disorder.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Epilepsy, severe kidney disease, use of contraindicated medications, suicide intent, substance dependence and pregnancy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment was conducted by numbering each container for each participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random order generation using a randomisation table created by computer software. Randomnisation table whereby each drug treatment is labelled as # a or b, where a or b is DCS or placebo. This order changes for each #.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
All therapists, assessors, and data entry staff are double blind.
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/06/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1541 0
Government body
Name [1] 1541 0
National Health and Medical Research Council
Country [1] 1541 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 1354 0
None
Name [1] 1354 0
Nil
Address [1] 1354 0
Country [1] 1354 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2971 0
University of New South Wales
Ethics committee address [1] 2971 0
Ethics committee country [1] 2971 0
Australia
Date submitted for ethics approval [1] 2971 0
Approval date [1] 2971 0
Ethics approval number [1] 2971 0
04145

Summary
Brief summary
The aim of this study is to evaluate the effectiveness of adding D-Cycloserine to group-based exposure therapy for panic disorder. It is hypothesised that individuals who receive D-Cycloserine and exposure therapy will attain a greater reduction in panic symptoms in comparison to individuals who receive placebo and exposure therapy. Participants from the community who have a primary diagnosis of panic disorder will receive three group based exposure therapy sessions in combination with placebo or D-Cycloserine. Exposure therapy consists of exposure to feared body sensations. Panic symptoms are assess one and three months later. All therapsists, assessors, and individuals entering data are blind to drug condition.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35290 0
Address 35290 0
Country 35290 0
Phone 35290 0
Fax 35290 0
Email 35290 0
Contact person for public queries
Name 10421 0
Adam Guastella
Address 10421 0
School of Psychology,
University of New South Wales
Kensington NSW 2052
Country 10421 0
Australia
Phone 10421 0
+61 2 93858071
Fax 10421 0
Email 10421 0
a.guastella@unsw.edu.au
Contact person for scientific queries
Name 1349 0
Adam Guastella
Address 1349 0
School of Psychology
University of New South Wales
Kensington NSW 2052
Country 1349 0
Australia
Phone 1349 0
+61 2 93858071
Fax 1349 0
Email 1349 0
a.guastella@unsw.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.