Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| German Federal Ministry of Education and Research | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
The present study is a multicenter study with two participating institutions: The "Klinik für Psychiatrie und Psychotherapie, Charité - Universitätsmedizin Berlin" and the "ZPHU - Zentrum für Psychotherapie am Institut für Psychologie, Humboldt-Universität zu Berlin". It is a randomized, placebo-controlled and double blind study with agoraphobic patients receiving a manualized cognitive behavioral therapy. The randomization and blindness refers to medication with an antibiotic called D-Cycloserine: One group receives D-Cycloserine after exposure sessions and the other group is treated with a placebo. The aim is to find out, whether or not D-Cycloserine augments psychotherapy outcome when administered after an exposure. Altogether, 78 patients will be treated. Before therapy, all patients receive a clinical examination to ensure that no contraindications for participating (like cardiac defects or serious central nervous system diseases) are present. In the following diagnostic sessions therapists conduct standardized assessments and after four diagnostic sessions therapy starts. All patients receive six therapy sessions, whereof three consist of exposures. When exposures are successful, D-Cycloserine or Placebo is administered afterwards. At the last therapy session another clinical examination to control several parameters is conducted. One month after therapy, two follow-up sessions with assessments take place.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D-Cycloserine + CBT | Experimental | Patients receiving CBT (cognitive behavioral therapy) and D-Cycloserine (3 times, 50 mg, oral) directly after an exposure |
|
| Placebo + CBT | Placebo Comparator | Patients receiving CBT (cognitive behavioral therapy) and a placebo pill (3 times, looking identical to the DCS pill) directly after an exposure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT | Behavioral | 12 sessions of CBT (cognitive behavioral therapy) with psychoeducation and in-vivo exposure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Panic- and Agoraphobia Rating Scale (PAS) | The PAS is designed for patients with agoraphobia or panic disorder who are at least 15 years old. It can be used to determine the severity of the disorder or to examine therapeutic success. There is a self-rating and a clinician-rating version available with 14 items each, yet the items are the same in both versions. Answers are given on a five-point Likert scale from "0" to "4" with higher scores indicating a higher severity. For determination of the severity of the disorder, 13 items are summed up, only item "U" (asking if panic attacks occur expected or unexpected) is not considered, resulting in scores between 0 and 52. There are also five sub scores if only special contents are of interest: Panic attacks, agoraphobic avoidance, anticipatory anxiety, disability, and worries about health. For the present study the German version of the questionnaire is used. | Change from Baseline to Posttreatment (5 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Beck Anxiety Inventory (BAI) | Change from Baseline to Posttreatment (5 weeks) and follow-up (9 weeks) | |
| Clinical Global Index (CGI) | Change from Baseline to Posttreatment (5 weeks) and follow-up (9 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate Variability | Furthermore HRV during the three exposure sessions will be investigated. | Change from Baseline to follow-up (9 weeks) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Andreas Ströhle, Prof. Dr. | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry and Psychotherapy, Charité Campus Mitte - Universitätsmedizin Berlin | Berlin | State of Berlin | 10117 | Germany |
Not provided
| Label | URL |
|---|---|
| Homepage of the research group for anxiety disorders of the Charité | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D000379 | Agoraphobia |
| D016584 | Panic Disorder |
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D003523 | Cycloserine |
| D003132 | Commerce |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D-Cycloserine | Drug | Administered for three times (50mg, oral) directly after exposure |
|
|
| Agoraphobic Cognitions, Body Sensations Questionnaire and Mobility Inventory (AKV) | Change from Baseline to Posttreatment (5 weeks) and follow-up (9 weeks) |
| Anxiety Sensitivity Index (ASI) | Change from Baseline to Posttreatment (5 weeks) and follow-up (9 weeks) |
| Beck Depression Inventory first revised(BDI II) | Change from Baseline to Posttreatment (5 weeks) and follow-up (9 weeks) |
| Brief Symptom Inventory (BSI) | Change from Baseline to Posttreatment (5 weeks) and follow-up (9 weeks) |
| D023303 |
| Oxazolidinones |
| D010080 | Oxazoles |
| D012694 | Serine |
| D021542 | Amino Acids, Neutral |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013676 | Technology, Industry, and Agriculture |