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Augmentation of Psychotherapy With D-Cycloserine in Agoraphobia (Exposure-DCS)

Primary Purpose

Agoraphobia

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
CBT
D-Cycloserine
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Agoraphobia focused on measuring agoraphobia, panic disorder, D-Cycloserine, DCS, exposure, cognitive behavioral therapy, CBT, augmentation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Psychiatry and Psychotherapy, Charité Campus Mitte - Universitätsmedizin Berlin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

D-Cycloserine + CBT

Placebo + CBT

Arm Description

Patients receiving CBT (cognitive behavioral therapy) and D-Cycloserine (3 times, 50 mg, oral) directly after an exposure

Patients receiving CBT (cognitive behavioral therapy) and a placebo pill (3 times, looking identical to the DCS pill) directly after an exposure

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Beck Anxiety Inventory (BAI)
Clinical Global Index (CGI)
Agoraphobic Cognitions, Body Sensations Questionnaire and Mobility Inventory (AKV)
Anxiety Sensitivity Index (ASI)
Beck Depression Inventory first revised(BDI II)
Brief Symptom Inventory (BSI)

Full Information

First Posted
July 26, 2013
Last Updated
May 16, 2014
Sponsor
Charite University, Berlin, Germany
Collaborators
German Federal Ministry of Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT01928823
Brief Title
Augmentation of Psychotherapy With D-Cycloserine in Agoraphobia
Acronym
Exposure-DCS
Official Title
Augmentation of Exposure Therapy With D-Cycloserine in Patients With Agoraphobia With or Without Panic Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
German Federal Ministry of Education and Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agoraphobia
Keywords
agoraphobia, panic disorder, D-Cycloserine, DCS, exposure, cognitive behavioral therapy, CBT, augmentation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
D-Cycloserine + CBT
Arm Type
Experimental
Arm Description
Patients receiving CBT (cognitive behavioral therapy) and D-Cycloserine (3 times, 50 mg, oral) directly after an exposure
Arm Title
Placebo + CBT
Arm Type
Placebo Comparator
Arm Description
Patients receiving CBT (cognitive behavioral therapy) and a placebo pill (3 times, looking identical to the DCS pill) directly after an exposure
Intervention Type
Behavioral
Intervention Name(s)
CBT
Intervention Description
12 sessions of CBT (cognitive behavioral therapy) with psychoeducation and in-vivo exposure
Intervention Type
Drug
Intervention Name(s)
D-Cycloserine
Other Intervention Name(s)
"Seromycin" by Eli Lilly and Company
Intervention Description
Administered for three times (50mg, oral) directly after exposure
Primary Outcome Measure Information:
Title
Panic- and Agoraphobia Rating Scale (PAS)
Description
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.
Time Frame
Change from Baseline to Posttreatment (5 weeks)
Secondary Outcome Measure Information:
Title
Beck Anxiety Inventory (BAI)
Time Frame
Change from Baseline to Posttreatment (5 weeks) and follow-up (9 weeks)
Title
Clinical Global Index (CGI)
Time Frame
Change from Baseline to Posttreatment (5 weeks) and follow-up (9 weeks)
Title
Agoraphobic Cognitions, Body Sensations Questionnaire and Mobility Inventory (AKV)
Time Frame
Change from Baseline to Posttreatment (5 weeks) and follow-up (9 weeks)
Title
Anxiety Sensitivity Index (ASI)
Time Frame
Change from Baseline to Posttreatment (5 weeks) and follow-up (9 weeks)
Title
Beck Depression Inventory first revised(BDI II)
Time Frame
Change from Baseline to Posttreatment (5 weeks) and follow-up (9 weeks)
Title
Brief Symptom Inventory (BSI)
Time Frame
Change from Baseline to Posttreatment (5 weeks) and follow-up (9 weeks)
Other Pre-specified Outcome Measures:
Title
Heart Rate Variability
Description
Furthermore HRV during the three exposure sessions will be investigated.
Time Frame
Change from Baseline to follow-up (9 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Ströhle, Prof. Dr.
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry and Psychotherapy, Charité Campus Mitte - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.angstambulanz-charite.de
Description
Homepage of the research group for anxiety disorders of the Charité

Learn more about this trial

Augmentation of Psychotherapy With D-Cycloserine in Agoraphobia

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