D-cycloserine-supported exposure in patients with panic disorder
| ISRCTN | ISRCTN44960833 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44960833 |
| EudraCT/CTIS number | 2006-004860-29 |
| Secondary identifying numbers | 2006-004860-29 |
- Submission date
- 01/10/2007
- Registration date
- 27/03/2008
- Last edited
- 17/03/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
Department of Psychiatry and Psychotherapy
Campus Charite Mitte
Charite - Universitatsmedizin Berlin
Chariteplatz 1
Berlin
10117
Germany
| Phone | +49 (0)30 450 517 034 |
|---|---|
| Andreas.Stroehle@charite.de |
Study information
| 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 |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | D-cycloserine-supported exposure in patients with panic disorder |
| Study acronym | Panik-Cyclo |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 01/04/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | Both |
| Target number of participants | 44 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2007 |
| Date of final enrolment | 01/04/2009 |
Locations
Countries of recruitment
- Germany
Study participating centre
10117
Germany
Sponsor information
Hospital/treatment centre
c/o Privat-Dozent Dr Andreas Strohle
Department of Psychiatry and Psychotherapy
Campus Charite Mitte
Chariteplatz 1
Berlin
10117
Germany
| Phone | +49 (0)30 450 517 034 |
|---|---|
| andreas.stroehle@charite.de | |
| Website | http://www.charite.de/ |
"ROR" |
https://ror.org/001w7jn25 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Federal Ministry of Education and Research, BMBF
- Location
- Germany
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2011 | Yes | No |
Editorial Notes
17/03/2017: Plain English summary added.
