Augmentation of Psychotherapy With D-Cycloserine in Agoraphobia

NCT01928823 | Completed Phase 2 DMC

• 1 other identifier: 221013
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Agoraphobia

Keywords

agoraphobia; panic disorder; D-Cycloserine; DCS; exposure; cognitive behavioral therapy; CBT; augmentation

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (6)

• 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)

• 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)

Other Outcomes (1)

• Heart Rate Variability

  Change from Baseline to follow-up (9 weeks)

Study Arms (2)

D-Cycloserine + CBT

EXPERIMENTAL

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

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

Behavioral: CBT

Interventions

CBT BEHAVIORAL

12 sessions of CBT (cognitive behavioral therapy) with psychoeducation and in-vivo exposure

D-Cycloserine + CBT; Placebo + CBT

D-Cycloserine DRUG

Administered for three times (50mg, oral) directly after exposure

Also known as: "Seromycin" by Eli Lilly and Company

D-Cycloserine + CBT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• German Federal Ministry of Education and Research: collaborator

Study Sites (1)

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

Berlin, State of Berlin, 10117, Germany

Location

Related Links

• Homepage of the research group for anxiety disorders of the Charité

MeSH Terms

Conditions

Agoraphobia; Panic Disorder

Interventions

Cycloserine; Commerce

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins; Technology, Industry, and Agriculture

Study Officials

• Andreas Ströhle, Prof. Dr.

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant medical director

Study Record Dates

• First Submitted: July 26, 2013
• First Posted: August 27, 2013
• Study Start: November 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 19, 2014

Record last verified: 2014-05

Locations

DE (1)