D-cycloserine-supported exposure in patients with panic disorder

• Register: ISRCTN
• Last refreshed on: 18 April 2017
• Main ID: ISRCTN44960833
• Date of registration: 27/03/2008
• Prospective Registration: No
• Primary sponsor: Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)
• Public title: D-cycloserine-supported exposure in patients with panic disorder
• Scientific title: D-cycloserine-supported exposure in patients with panic disorder
• Date of first enrolment: 01/10/2007
• Target sample size: 44
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN44960833
• Study type: Interventional
• Study design: Double-blind randomised placebo-controlled study (Treatment)
• Phase: Not Applicable

Countries of recruitment

Germany

Contacts

• Name: Andreas Strohle

Key inclusion & exclusion criteria

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
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Panic disorder with agoraphobia
Mental and Behavioural Disorders
Anxiety disorders

Intervention(s)

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.

Primary Outcome(s)

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(s)

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.

Secondary ID(s)

2006-004860-29

Source(s) of Monetary Support

Bundesministerium für Bildung und Forschung (ref: 01GV0612)