Condition category
Mental and Behavioural Disorders
Date applied
12/11/2009
Date assigned
08/12/2009
Last edited
08/12/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.charite.de/

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

Publication citations

Additional files

Editorial Notes