Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
D-Cycloserine · 1 trial · 1 indication
The main outcome was a composite Z-score from the Liebowitz Social Anxiety Scale (LSAS) and the Social Phobic Disorders Severity and Change Form (SPD-SC Form). "The Composite Z-score of the LSAS and SPD-SC Form indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of a reference population. Negative numbers indicate values lower symptom severity and positive numbers indicate higher symptom severity. The LSAS is a 24-item scale that measures fear and avoidance in social and performance situations within the last week, using 0 (no fear/never avoids) to 3 (severe fear/usually avoids) scale. LSAS scores range from 0-144 with higher scores indicated worse outcomes. The SPD-S is the Clinical Global Impression Scale27 adapted for SAD, which instructs evaluators to use a 7-point scale (1=normal, not at all ill; 7=among the most extremely ill patients) to index the severity of social anxiety.
| Arm | Type | Description |
|---|---|---|
| Tailored Post-Session DCS | EXPERIMENTAL | Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one placebo before and one dcs/placebo after the session). The type of pill (i.e. dcs vs. placebo) will be determined after the session. |
| Pre-Session DCS | ACTIVE_COMPARATOR | Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one dcs before and one placebo after the session). |
| Placebo | PLACEBO_COMPARATOR | Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one placebo before and one placebo after the session). |
| Non-Tailored Post-Session DCS | ACTIVE_COMPARATOR | Individuals in this condition will receive 5 weeks of CBT for social anxiety disorder and two pills (i.e. one placebo before and one dcs after the session). |
| Name | Type | Description |
|---|---|---|
| D-Cycloserine | DRUG | D-cycloserine is a medication thought to be associated with fear extinction. |
| Placebo | DRUG | Sugar pill |
| Cognitive Behavioral Therapy | BEHAVIORAL | This will be a 5-session version of a group CBT protocol with 4-6 patients and 2 therapists per group emphasizing repeated exposure practices. Session 1 involves an introduction and orientation to the CBT model. Sessions 2-5 emphasize repeated exposure tasks, which consist of role-play activities to confront fearful situations in a group setting while disputing cognitive distortions (coupled with the fading of safety behaviors). At the conclusion of each exposure session, patients will be encouraged to continue to apply home-practice strategies (such as giving speeches in front of a mirror). Continued practice of the interventions will be considered part of treatment, and patients will be asked to refrain from alternative treatment for four weeks following completion of the last treatment session. |
Inclusion Criteria: * Male or female outpatients \> 18 years of age with a primary psychiatric diagnosis (designated by the patient as the most important source of current distress) of social anxiety disorder as defined by DSM-5 criteria. * A total score \> 60 on the LSAS. * Physical examination an...
D-Cycloserine is an investigational small molecule being studied for the treatment of Social Anxiety Disorder. It is being developed as an adjunct to cognitive behavioral therapy (CBT) to enhance the therapy's effects. The drug is currently in early clinical development and is not yet approved for any use.
D-Cycloserine is being developed by Jasper Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol JSPR. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with Social Anxiety Disorder.
D-Cycloserine is in Phase 1 clinical development. A completed early Phase 1 trial has evaluated the drug in 152 participants. The drug remains investigational and has not received FDA approval. Further clinical studies would be needed to establish its safety and effectiveness.
D-Cycloserine has been studied in one completed clinical trial, identified as NCT02066792. This early Phase 1 study, titled "Dose Timing of D-Cycloserine to Augment CBT for Social Anxiety Disorder," enrolled 152 participants in the United States. The trial was randomized, double-blind, and placebo-controlled.
D-Cycloserine is a specific form of the antibiotic cycloserine. While both share the same core chemical structure, D-Cycloserine refers to the D-isomer, which is the active form being investigated for psychiatric use. The drug is being studied specifically for its potential to augment cognitive behavioral therapy in Social Anxiety Disorder.