BNC210 for Social Anxiety Disorder

(AFFIRM-1 Trial)

Recruiting at 19 trial locations

Overseen By BNC210 Clinical Studies Bionomics Limited

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Bionomics Limited

Must not be taking: Psychotropics, Benzodiazepines

Disqualifiers: Bipolar, Schizophrenia, Alcohol-use, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 day

332 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to evaluate the effect of a single, acute dose of BNC210 compared to placebo on reducing the severity of anxiety provoked by a behavioral assessment task and measured using the Subjective Units of Distress Scale (SUDS) in adult patients with social anxiety disorder.

Will I have to stop taking my current medications?

Yes, you will need to stop taking psychotropic medications (drugs that affect your mind, emotions, and behavior) at least 30 days before the screening, and you must not use benzodiazepines daily for 90 days before the screening.

What evidence supports the effectiveness of the drug BNC210 for treating social anxiety disorder?

While there is no direct evidence for BNC210, studies show that medications like selective serotonin reuptake inhibitors (SSRIs) are effective for social anxiety disorder, suggesting that drugs targeting similar pathways might also be beneficial. ^{1 2 3 4 5}

How is the drug BNC210 different from other treatments for social anxiety disorder?

BNC210 is unique because it is being studied specifically for social anxiety disorder, whereas other treatments like second-generation antidepressants and olanzapine are used more broadly for anxiety and mood disorders. This focus might offer a more targeted approach for those with social anxiety. ^{6 7 8 9 10}

Eligibility Criteria

This trial is for adults with social anxiety disorder who score at least 60 on the Liebowitz Social Anxiety Scale, indicating significant symptoms. Participants must be able to swallow tablets and use suitable contraception as per protocol.

Inclusion Criteria

I am using birth control as required by the study.

I can swallow pills.

I have been diagnosed with social anxiety disorder.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-3 weeks

1 visit (in-person)

Treatment

Participants receive a single dose of 225 mg BNC210 or placebo and participate in a behavioral assessment task

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (phone/video conference)

Treatment Details

Interventions

• BNC210

Trial Overview The study tests if a single dose of BNC210 can reduce anxiety levels more effectively than a placebo in people with social anxiety disorder. Anxiety reduction is measured during a specific task using the Subjective Units of Distress Scale.

Participant Groups

Group I: 225 mg BNC210 Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Bionomics Limited

Lead Sponsor

Trials

8

Recruited

1,100+

Findings from Research

Patients with early-onset social anxiety disorder (SAD) are more likely to experience inactivity, have a generalized subtype of social phobia, and present with psychiatric comorbidities compared to those with late-onset SAD, indicating a distinct clinical profile.

Despite these differences in presentation, both early-onset and late-onset patients showed similar severity of symptoms and therapeutic responses after at least ten weeks of drug treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early-onset social anxiety disorder in adults: clinical and therapeutic features. Menezes, GB., Fontenelle, LF., Versiani, M.[2019]

Social anxiety disorder (SAD) is a chronic condition that often begins in adolescence and can persist throughout life if untreated, with a significant number of patients also experiencing comorbid mental health issues.

Selective serotonin reuptake inhibitors (SSRIs) have emerged as the first-line treatment for SAD due to their proven safety, tolerability, and efficacy, while ongoing research aims to improve treatment outcomes and prevent relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating neurobiology and psychopathology into evidence-based treatment of social anxiety disorder. Liebowitz, MR., Ninan, PT., Schneier, FR., et al.[2022]

Selective serotonin reuptake inhibitors (SSRIs) are currently considered the first-line treatment for social anxiety disorder due to their proven safety, tolerability, and efficacy.

Other medications like clonazepam, bromazepam, and gabapentin show potential efficacy similar to SSRIs, but more research is needed to confirm their effectiveness, while phenelzine is reserved for cases that do not respond to SSRIs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapy of social anxiety disorder. Blanco, C., Antia, SX., Liebowitz, MR.[2022]

A new, comprehensive treatment for severe social phobia has shown effectiveness in a pilot study, particularly for individuals with co-occurring mental health conditions.

The treatment resulted in significant improvements across various outcome measures, highlighting the importance of a multifaceted approach to effectively address social phobia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multicomponent behavioral treatment for social phobia: social effectiveness therapy. Turner, SM., Beidel, DC., Cooley, MR., et al.[2019]

A systematic review of 51 randomized controlled trials involving 9914 participants found that pharmacotherapy for social anxiety disorder (SAD) is effective, with over 55% of participants responding positively to treatment after an average of 12 weeks.

Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) were identified as the most effective and well-tolerated medication classes for SAD, while beta-blockers showed insufficient evidence for treating performance anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapy for social anxiety disorder: a systematic review. Ipser, JC., Kariuki, CM., Stein, DJ.[2018]

In a study of 200 bipolar disorder patients, 17.5% were found to have comorbid social anxiety disorder (SAD), which was linked to more severe episodes and an earlier onset of bipolar disorder.

Despite the increased severity of episodes in patients with SAD, there was no significant difference in treatment response to mood stabilizers like lithium and anticonvulsants between those with and without SAD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of clinical and sociodemographic features of bipolar disorder patients with those of social anxiety disorder patients comorbid with bipolar disorder in Turkey. Berkol, TD., Kırlı, E., Islam, S., et al.[2018]

A systematic review of 27 clinical trials involving second-generation antidepressants (SGA) showed that these medications significantly reduce symptoms of social anxiety disorder (SAD) compared to placebo, with a mean reduction in Liebowitz Social Anxiety Scale scores of -11.9.

The analysis indicated a 62% increase in treatment response for patients using SGAs, but no significant differences in efficacy were found among the various second-generation antidepressants tested.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Second-generation antidepressants in social anxiety disorder: meta-analysis of controlled clinical trials. de Menezes, GB., Coutinho, ES., Fontenelle, LF., et al.[2021]

In an 8-week study involving 12 patients with social anxiety disorder, olanzapine showed significant improvement compared to placebo on key anxiety measures, indicating its potential efficacy as a treatment.

Both olanzapine and placebo were well tolerated, with olanzapine causing more drowsiness and dry mouth but negligible weight gain, suggesting a favorable safety profile for further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of olanzapine in social anxiety disorder: a pilot study. Barnett, SD., Kramer, ML., Casat, CD., et al.[2018]

The adapted 'Bergen 4-Day Treatment' for severe social anxiety disorder led to a significant 48% reduction in symptoms for a 16-year-old girl after just three days of treatment.

At the 28-month follow-up, the girl no longer met the diagnostic criteria for social anxiety disorder, indicating the long-term efficacy of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-year longitudinal case study of intensive exposure treatment in an adolescent girl with social anxiety disorder. Haukeli, K., Edlund, K.[2022]

In a 12-week open trial with 21 patients suffering from social phobia, buspirone showed modest efficacy, with 47% of participants rated as much to very much improved in their symptoms by the end of the study.

Among those who tolerated higher doses of 45 mg/day or more, 67% experienced significant improvement, indicating that higher doses may enhance the treatment's effectiveness for social phobia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buspirone in social phobia. Schneier, FR., Saoud, JB., Campeas, R., et al.[2013]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

Early-onset social anxiety disorder in adults: clinical and therapeutic features. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Integrating neurobiology and psychopathology into evidence-based treatment of social anxiety disorder. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Pharmacotherapy of social anxiety disorder. [2022]

4. England pubmed.ncbi.nlm.nih.gov

A multicomponent behavioral treatment for social phobia: social effectiveness therapy. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Pharmacotherapy for social anxiety disorder: a systematic review. [2018]

6. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Comparison of clinical and sociodemographic features of bipolar disorder patients with those of social anxiety disorder patients comorbid with bipolar disorder in Turkey. [2018]

7. Germany pubmed.ncbi.nlm.nih.gov

Second-generation antidepressants in social anxiety disorder: meta-analysis of controlled clinical trials. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Efficacy of olanzapine in social anxiety disorder: a pilot study. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Two-year longitudinal case study of intensive exposure treatment in an adolescent girl with social anxiety disorder. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Buspirone in social phobia. [2013]