Augmentation of Psychotherapy With D-Cycloserine in Agoraphobia

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Since decades, D-Cycloserine (DCS, drug class: Oxazolidinone) is proven to be an effective antibiotic agent in the treatment of tuberculosis. Furthermore it takes action in the central nervous system as an partial agonist on NMDA receptors. Because of glutamate mediated neuronal long-term potentiation in long-term memory DCS has an augmenting effect on emotional learning, as it occurs in exposure therapy of anxiety disorders. In this context we use DCS in addition to exposure therapy as a part of cognitive behavioral therapy (CBT) in patients suffering from agoraphobia with or without panic disorder. Thereby DCS is applicated oral as a capsule of 50mg, on three consecutive therapy sessions.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Collaborator: German Federal Ministry of Education and Research
• Treatments: Cycloserine

Criteria

Inclusion Criteria:

• written consent (as per AMG §40 (1) 3b)

• diagnosis of agoraphobia; severity of the disorder due to the CGI should at least be "moderately ill"

• age: 18-75 years

• negative pregnancy test for premenopausal women and safe contraception (Pearlindex < 1) during the study

• accessibility (geographical vicinity) for treatment and follow-up

• Compliance of the patient

Exclusion Criteria:

• Known overreaction after taking of D-Cycloserine

• Actual pharmacotherapy with ethionamides and/ or isoniazide

• Judicial or regulatory hospitalization in a mental institution (as per AMG §40 (1) 4)

• Severe psychiatric disorder like schizophrenia, addiction or dementia

• acute suicidal tendency

• epilepsy or other diseases concerning the CNS (e.g. brain tumor, encephalitis)

• internal disease like severe hypertension, cardiac insufficiency, cardiac arrhythmia, severe dysfunction of liver or kidney, insulin-dependent diabetes mellitus or disorders of the hematopoiesis

• lactation

• changes in a psychopharmacotherapy or discontinuation of a pretreatment with psychoactive drugs less than 4 weeks previous to the begin of the study

• disturbance of the day and night rhythm

• disorder-specific psychotherapy

• participation in another AMG-study during the last month previous to the inclusion in the study or during the participation in this study