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

May 16, 2014 updated by: Prof. Dr. Andreas Ströhle, Charite University, Berlin, Germany

Augmentation of Exposure Therapy With D-Cycloserine in Patients With Agoraphobia With or Without Panic Disorder

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Department of Psychiatry and Psychotherapy, Charité Campus Mitte - Universitätsmedizin Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: D-Cycloserine + CBT
Patients receiving CBT (cognitive behavioral therapy) and D-Cycloserine (3 times, 50 mg, oral) directly after an exposure
Behavioral: CBT
12 sessions of CBT (cognitive behavioral therapy) with psychoeducation and in-vivo exposure
Drug: D-Cycloserine
Administered for three times (50mg, oral) directly after exposure
Other Names:
  • "Seromycin" by Eli Lilly and Company
PLACEBO_COMPARATOR: Placebo + CBT
Patients receiving CBT (cognitive behavioral therapy) and a placebo pill (3 times, looking identical to the DCS pill) directly after an exposure
Behavioral: CBT
12 sessions of CBT (cognitive behavioral therapy) with psychoeducation and in-vivo exposure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Panic- and Agoraphobia Rating Scale (PAS)
Time Frame: Change from Baseline to Posttreatment (5 weeks)

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)

Secondary Outcome Measures

Outcome Measure
Time Frame
Beck Anxiety Inventory (BAI)
Time Frame: Change from Baseline to Posttreatment (5 weeks) and follow-up (9 weeks)
Change from Baseline to Posttreatment (5 weeks) and follow-up (9 weeks)
Clinical Global Index (CGI)
Time Frame: Change from Baseline to Posttreatment (5 weeks) and follow-up (9 weeks)
Change from Baseline to Posttreatment (5 weeks) and follow-up (9 weeks)
Agoraphobic Cognitions, Body Sensations Questionnaire and Mobility Inventory (AKV)
Time Frame: Change from Baseline to Posttreatment (5 weeks) and follow-up (9 weeks)
Change from Baseline to Posttreatment (5 weeks) and follow-up (9 weeks)
Anxiety Sensitivity Index (ASI)
Time Frame: Change from Baseline to Posttreatment (5 weeks) and follow-up (9 weeks)
Change from Baseline to Posttreatment (5 weeks) and follow-up (9 weeks)
Beck Depression Inventory first revised(BDI II)
Time Frame: Change from Baseline to Posttreatment (5 weeks) and follow-up (9 weeks)
Change from Baseline to Posttreatment (5 weeks) and follow-up (9 weeks)
Brief Symptom Inventory (BSI)
Time Frame: Change from Baseline to Posttreatment (5 weeks) and follow-up (9 weeks)
Change from Baseline to Posttreatment (5 weeks) and follow-up (9 weeks)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate Variability
Time Frame: Change from Baseline to follow-up (9 weeks)
Furthermore HRV during the three exposure sessions will be investigated.
Change from Baseline to follow-up (9 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

German Federal Ministry of Education and Research

Investigators

  • Principal Investigator: Andreas Ströhle, Prof. Dr., Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (ACTUAL)

May 1, 2014

Study Completion (ACTUAL)

May 1, 2014

Study Registration Dates

First Submitted

July 26, 2013

First Submitted That Met QC Criteria

August 22, 2013

First Posted (ESTIMATE)

August 27, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 19, 2014

Last Update Submitted That Met QC Criteria

May 16, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 221013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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