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D-Cycloserine

Phase 2

Agoraphobia | Small molecule | Other |Pulmonx Corporation|Last Updated: May 19, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment73

FDA Designations

No designations recorded

Clinical trial landscape

D-Cycloserine · 1 trial · 1 indication

Phase 2 1
NCT01928823Augmentation of Psychotherapy With D-Cycloserine in AgoraphobiaAgoraphobia
COMPLETED73 Analytics
PHASE2COMPLETED
Augmentation of Psychotherapy With D-Cycloserine in Agoraphobia
AgoraphobiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Panic- and Agoraphobia Rating Scale (PAS)
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.

Secondary Endpoints

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)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
D-Cycloserine + CBTEXPERIMENTALPatients receiving CBT (cognitive behavioral therapy) and D-Cycloserine (3 times, 50 mg, oral) directly after an exposure
Placebo + CBTPLACEBO_COMPARATORPatients receiving CBT (cognitive behavioral therapy) and a placebo pill (3 times, looking identical to the DCS pill) directly after an exposure

Interventions

NameTypeDescription
CBTBEHAVIORAL12 sessions of CBT (cognitive behavioral therapy) with psychoeducation and in-vivo exposure
D-CycloserineDRUGAdministered for three times (50mg, oral) directly after exposure
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

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 * acce...

Countries:Germany
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