Condition category
Mental and Behavioural Disorders
Date applied
01/10/2007
Date assigned
27/03/2008
Last edited
23/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 3

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

Acronym

Panik-Cyclo

Study hypothesis

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

Ethics approval

The study was approved by the Local Ethics Committee (Ausschuss 4 der Ethikkommission des Landes Berlin) on 03/01/2007 (Identification Number: EK 5 618/06) and was conducted in accordance with the declaration of Helsinki, the German Medicines Act (AMG), and the guidelines of the International Conference on Harmonisation for Good Clinical Practice.

Study design

Double-blind randomised placebo-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

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

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 Specified

Drug names

D-cycloserine

Primary outcome measures

Panic and Agoraphobia Scale.

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.

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

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

Department of Psychiatry and Psychotherapy
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

http://www.charite.de/

Funders

Funder type

Government

Funder name

German Federal Ministery of Education and Research (Bundesministerium für Bildung und Forschung) (Germany) (ref: 01GV0612)

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

2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21377691

Publication citations

  1. Results

    Siegmund A, Golfels F, Finck C, Halisch A, Räth D, Plag J, Ströhle A, D-cycloserine does not improve but might slightly speed up the outcome of in-vivo exposure therapy in patients with severe agoraphobia and panic disorder in a randomized double blind clinical trial., J Psychiatr Res, 2011, 45, 8, 1042-1047, doi: 10.1016/j.jpsychires.2011.01.020.

Additional files

Editorial Notes