AgoraphobiaPhase 2Exposure-DCSNCT01928823
Augmentation of Psychotherapy With D-Cycloserine in Agoraphobia
A Phase 2 study testing CBT and D-Cycloserine in people with Agoraphobia, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Agoraphobia
- What is being tested?
- CBT and D-Cycloserine
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2011to May 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry and Psychotherapy, Charité Campus Mitte - Universitätsmedizin Berlin
Berlin, State of Berlin, 10117
About this study
Official title: 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.
Read the 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.
- Conditions
- Agoraphobia
- Being tested
- CBT, D-Cycloserine
- Keywords
- agoraphobia, panic disorder, D-Cycloserine, DCS, exposure, cognitive behavioral therapy, CBT, augmentation
- Medical subject headings
- Agoraphobia, Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBTBehavioural
12 sessions of CBT (cognitive behavioral therapy) with psychoeducation and in-vivo exposure
D-CycloserineDrug
Also called "Seromycin" by Eli Lilly and Company
Administered for three times (50mg, oral) directly after exposure
| Study group | Role | What they receive |
|---|---|---|
| D-Cycloserine + CBT | Experimental | Patients receiving CBT (cognitive behavioral therapy) and D-Cycloserine (3 times, 50 mg, oral) directly after an exposure Receives: Behavioral: CBT; Drug: D-Cycloserine |
| 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 Receives: Behavioral: CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline to Posttreatment (5 weeks)
Secondary outcomes (6)
Beck Anxiety Inventory (BAI)
Measured: Change from Baseline to Posttreatment (5 weeks) and follow-up (9 weeks)
Clinical Global Index (CGI)
Measured: Change from Baseline to Posttreatment (5 weeks) and follow-up (9 weeks)
Agoraphobic Cognitions, Body Sensations Questionnaire and Mobility Inventory (AKV)
Measured: Change from Baseline to Posttreatment (5 weeks) and follow-up (9 weeks)
Anxiety Sensitivity Index (ASI)
Measured: Change from Baseline to Posttreatment (5 weeks) and follow-up (9 weeks)
Beck Depression Inventory first revised(BDI II)
Measured: Change from Baseline to Posttreatment (5 weeks) and follow-up (9 weeks)
Brief Symptom Inventory (BSI)
Measured: Change from Baseline to Posttreatment (5 weeks) and follow-up (9 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2013 (estimated)
- Study startNov 2011
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgoraphobiaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Principal investigator, Prof. Dr. Andreas Ströhle, Charite University, Berlin, Germany
- Investigators
- Andreas Ströhle, Prof. Dr., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928823
- Sponsor's protocol ID
- 221013
- Acronym
- Exposure-DCS
- Status last verified
- May 2014
- First submitted
- 26 Jul 2013
- Last updated
- 19 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmentation of Exposure Therapy With D-Cycloserine in Patients With Agoraphobia With or Without Panic Disorder
- ClinicalTrials.gov ID
- NCT01928823
- Acronym / sponsor ID
- Exposure-DCS / 221013
- Conditions
- Agoraphobia
- Keywords
- agoraphobia, panic disorder, D-Cycloserine, DCS, exposure, cognitive behavioral therapy, CBT, augmentation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Nov 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 27 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D-Cycloserine + CBT | Experimental | Behavioral: CBT, Drug: D-CycloserinePatients receiving CBT (cognitive behavioral therapy) and D-Cycloserine (3 times, 50 mg, oral) directly after an exposure |
| Placebo + CBT | Placebo comparator | Behavioral: CBTPatients receiving CBT (cognitive behavioral therapy) and a placebo pill (3 times, looking identical to the DCS pill) directly after an exposure |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT12 sessions of CBT (cognitive behavioral therapy) with psychoeducation and in-vivo exposure | Behavioural | D-Cycloserine + CBT, Placebo + CBT |
| D-CycloserineAlso: "Seromycin" by Eli Lilly and CompanyAdministered for three times (50mg, oral) directly after exposure | Drug | D-Cycloserine + CBT |
Primary outcome
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.
6 secondary outcomes
Beck Anxiety Inventory (BAI)
Time frame: 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)
Agoraphobic Cognitions, Body Sensations Questionnaire and Mobility Inventory (AKV)
Time frame: 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)
Beck Depression Inventory first revised(BDI II)
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Ströhle, Prof. Dr. principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CBT and D-Cycloserine in people with Agoraphobia, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Panic- and Agoraphobia Rating Scale (PAS) (time frame: Change from Baseline to Posttreatment (5 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2014.