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
Study website
Contact information
Type
Scientific
Contact name
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/CTIS number
2006-004860-29
IRAS number
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(s)
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
Study setting(s)
Other
Study 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
Pharmaceutical study type(s)
Phase
Not Applicable
Drug/device/biological/vaccine name(s)
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 study start date
01/10/2007
Overall study 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(s)
Patient
Age group
Adult
Lower age limit
18 Years
Upper age limit
75 Years
Sex
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
Study participating centre
Charite - Universitatsmedizin Berlin
Berlin
10117
Germany
Sponsor information
Organisation
Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)
Sponsor details
c/o Privat-Dozent Dr Andreas Strohle
Department of Psychiatry and Psychotherapy
Campus Charite Mitte
Chariteplatz 1
Berlin
10117
Germany
+49 (0)30 450 517 034
andreas.stroehle@charite.de
Sponsor type
Hospital/treatment centre
Website
ROR
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
National government
Location
Germany
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 01/08/2011 | Yes | No |