Contact information
Type
Scientific
Primary contact
Prof Andreas Ströhle
ORCID ID
Contact details
Clinic of Psychiatry and Psychotherapy
Campus Charité Mitte
Charitéplatz 1
Berlin
10117
Germany
+49 (0)30 450 517 034
Andreas.Stroehle@charite.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Association of the neuroendocrine parameters of cortisol and adrenocorticotropin hormone (ACTH) during repeated exposure therapy with long-lasting therapy outcome in patients with panic disorder and agoraphobia: an observational study
Acronym
Study hypothesis
During exposure, patients will release higher concentrations of stress hormones compared to controls. Concentrations of stress hormones during exposure will be related to therapy outcome.
Ethics approval
Local Ethics Committee (Ethikausschuss 1 am Campus Charité - Mitte, Berlin, Germany) approved on the 6th February 2007 (ref: EA1/199/06)
Study design
Observational case-control study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Panic disorder with agoraphobia
Intervention
Eight sessions of standardised and manualised cognitive behavioural group-therapy for panic disorder and agoraphobia plus three individual exposure therapy sessions employing flooding technique, were administered. Before, during and after exposure therapy, blood samples were drawn via an indwelling catheter from each patient.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Concentrations of cortisol and adrenocorticotropin hormone (ACTH) during exposure training
2. Panic and Agoraphobia Scale after therapy and at follow-up
Secondary outcome measures
1. Mobility Inventory for Agoraphobia after therapy and at follow-up
2. Beck Depression Inventory after therapy and at follow-up
3. Beck Anxiety Inventory after therapy and at follow-up
4. Hamilton Rating Scale for Depression after therapy and at follow-up
5. Hamilton Rating Scale for Anxiety after therapy and at follow-up
6. Clinical Global Impression after therapy and at follow-up
Overall trial start date
01/03/2007
Overall trial end date
01/03/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Subject familiarised with experimental procedure and had given written informed consent
2. Diagnosis of panic disorder with agoraphobia according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM IV), at least "moderately ill"
3. Aged 18 - 75 years, either sex
4. Sufficiently able to communicate with investigator, answer questions and fill in questionnaires
5. Reachability of patient for treatment and follow-up
6. Complience of patient
7. Undisturbed day-night rhythm
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
10 patients and 10 matched healthy controls
Participant exclusion criteria
1. Inability to give informed consent
2. Hospitalisation in a mental institution
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 internal medical illness, e.g., 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 8 weeks or discontinuation of psychopharmacological treatment within less than 2 weeks before beginning of the study
9. Recent interference with diurnal cycle
10. Current psychotherapeutic treatment specific for panic disorder and/or agoraphobia
11. Participation in other study within last month before beginning of the study or during the study
Recruitment start date
01/03/2007
Recruitment end date
01/03/2008
Locations
Countries of recruitment
Germany
Trial participating centre
Clinic of Psychiatry and Psychotherapy
Berlin
10117
Germany
Sponsor information
Organisation
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Sponsor details
c/o Professor Dr Andreas Ströhle
Clinic of Psychiatry and Psychotherapy
Campus Charité Mitte
Charitéplatz
Berlin
10117
Germany
+49 (0)30 450 517 034
Andreas.Stroehle@charite.de
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany) (ref: 01 GV 0612)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary