ISRCTN - ISRCTN44960833: D-cycloserine-supported exposure in patients with panic disorder

Plain English Summary

Background and study aims
Agoraphobia is a fear of being in situations where escape might be difficult or that help wouldn't be available if things go wrong. It usually develops as a complication of panic disorder, an anxiety disorder involving panic attacks and moments of intense fear. Agoraphobia can be treated with cognitive behavioural therapy (CBT), a talking therapy that can help patients manage their problems by changing the way they think and behave. CBT uses a type of therapy called exposure therapy, which involves being gradually exposed to the feared situation and using relaxation techniques and breathing exercises to help reduce anxiety. The aim of this study is to find out whether exposure therapy can be improved with the use of the drug D-cycloserine.

Who can participate?
Patients age 18-75 with panic disorder and agoraphobia

What does the study involve?
All participants undergo CBT consisting of eight group sessions within 1 month plus three individual exposure therapy sessions. One hour before the start of each exposure session, participants are randomly allocated to receive either D-cycloserine or a placebo (dummy drug). Panic and agoraphobia symptoms are measured at the start of the study, at the end of therapy (1 month after the start of the therapy), and at 2 and 6 months after the start of the therapy.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Charite - Universitatsmedizin Berlin (Germany)

When is the study starting and how long is it expected to run for?
October 2007 to April 2009

Who is funding the study?
Federal Ministry for Education and Research (Germany)

Who is the main contact?
Dr Andreas Strohle
Andreas.Stroehle@charite.de

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andreas Strohle

ORCID ID

Contact details

Department of Psychiatry and Psychotherapy
Campus Charite Mitte
Charite - Universitatsmedizin Berlin
Chariteplatz 1
Berlin
10117
Germany
+49 (0)30 450 517 034
Andreas.Stroehle@charite.de

Additional identifiers

EudraCT number

2006-004860-29

ClinicalTrials.gov number

Protocol/serial number

2006-004860-29

Study information

Scientific title

D-cycloserine-supported exposure in patients with panic disorder

Acronym

Panik-Cyclo

Study hypothesis

Administration of D-cycloserine supports the therapeutic effect of exposure therapy in patients with panic disorder.

Ethics approval

Local Ethics Committee (Ausschuss 4 der Ethikkommission des Landes Berlin), 03/01/2007, ref: EK 5 618/06

Study design

Double-blind randomised placebo-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Panic disorder with agoraphobia

Intervention

All patients will undergo cognitive behavioural therapy consisting of eight group sessions (group size: 4-8) within one month plus three individual exposure therapy sessions in a standardised procedure. One hour before start of each exposure session, half of the patients will receive 50 mg of D-cycloserine orally, and half of the patients will receive a placebo.

Intervention type

Drug

Phase

Not Applicable

Drug names

D-cycloserine

Primary outcome measure

Panic and Agoraphobia Scale, measured at baseline, at the end of therapy (one month after start of the therapy), 2 months after start of therapy, 6 months after start of therapy.

Secondary outcome measures

1. Mobility Inventory for Agoraphobia
2. Beck Depression Inventory
3. Beck Anxiety Inventory
3. Hamilton Rating Scale for Depression
4. Hamilton Rating Scale for Anxiety
5. Clinical Global Impression

Outcomes will be measured at baseline, at the end of therapy (one month after start of the therapy), 2 months after start of therapy, 6 months after start of therapy.

Overall trial start date

01/10/2007

Overall trial end date

01/04/2009

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Subject familiarised with experimental procedure and had given written informed consent according to AMG §40(1)3b
2. Diagnosis of panic disorder with agoraphobia, at least "moderately ill"
3. Age: 18-75 years
4. Sufficiently able to communicate with investigator, answer questions and fill in questionnaires
5. If pre-menopausal female: negative pregnancy test and safe contraception during study period
6. Reachability of patient for treatment and follow-up
7. Compliance of patient

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

44

Participant exclusion criteria

1. Known overreaction to D-cycloserine
2. Hospitalisation in a mental institution according to AMG §40(1)4
3. Other psychiatric illnesses like schizophrenia, substance abuse or dementia
4. Acute suicidal tendency
5. Epilepsy or other illness of the central nervous system (CNS) (e.g. brain tumour, encephalitis)
6. Severe medical illness like severe hypertension, severe cardiac insufficiency, condition after acute myocardial infarction, cardiac arrhythmia of severity index IV or V according to Lown grade, severe dysfunction of liver or kidney, diabetes mellitus requiring insulin treatment, disturbances of haematopoiesis
7. Pregnancy or breastfeeding
8. Changes of psychopharmacological treatment within the last eight weaks or discontinuation of psychopharmacological treatment within less than four weeks before beginning of the study
9. Recent interference with diurnal cycle

Recruitment start date

01/10/2007

Recruitment end date

01/04/2009

Locations

Countries of recruitment

Germany

Trial participating centre

Charite - Universitatsmedizin Berlin
Berlin
10117
Germany

Sponsor information

Organisation

Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)

Sponsor type

Hospital/treatment centre

Website

http://www.charite.de/

Funders

Funder type

Government

Funder name

Bundesministerium für Bildung und Forschung (ref: 01GV0612)

Alternative name(s)

Federal Ministry of Education and Research, BMBF

Funding Body Type

government organisation

Funding Body Subtype

federal

Location