Cariprazine for Social Anxiety Disorder

Overseen By Matt T

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: The Medical Research Network

Must not be taking: Fluoxetine, MAOIs, Psychotropics, others

Disqualifiers: Schizophrenia, Bipolar, Substance use, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications before joining the trial. Specifically, you cannot take fluoxetine within 28 days of starting, and you must stop taking other psychotropic medications like SSRIs, SNRIs, and benzodiazepines at least 14 days before the trial begins.

How does the drug Cariprazine differ from other drugs for social anxiety disorder?

Cariprazine is unique because it is primarily used as an antipsychotic for conditions like schizophrenia and bipolar disorder, and its use for social anxiety disorder is novel. Unlike traditional treatments for social anxiety, which often include antidepressants or benzodiazepines, Cariprazine works by targeting dopamine receptors, which may offer a different approach to managing symptoms. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial tests Vraylar® to see if it can help people with social anxiety disorder by balancing brain chemicals related to mood and anxiety. Current treatments are not effective for everyone and often have side effects, so new options are needed.

Research Team

Michael R Liebowitz, MD

Principal Investigator

Managing Director

Eligibility Criteria

Inclusion Criteria

Subjects must have a minimum total score of 70 on the LSAS at both Screening and Baseline visits

Subjects must give written informed consent prior to any study procedures

Diagnosis of Social Anxiety Disorder (SAD) (300.23 Social Anxiety Disorder) according to DSM-5 criteria, as determined by psychiatric evaluation with the Investigator and confirmed by the Mini-International Neuropsychiatric Interview (MINI)

Exclusion Criteria

Subjects scoring >2 on item #3 of the HAM-D at Baseline, or who, in the opinion of the PI, are at a clinically significant risk for suicide

Systolic blood pressure ≥165 and/or diastolic blood pressure ≥95, as measured at Screening and Baseline visits

Positive Urine Drug Screen at the Baseline visit, unless due to prescribed medication

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Cariprazine or placebo for Social Anxiety Disorder in a double-blind, placebo-controlled trial

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Cariprazine
• Placebo

Participant Groups

Group I: Cariprazine Experimental Treatment 1 Intervention

Cariprazine 1.5 to 3 mg per day

Group II: Placebo Placebo Group 1 Intervention

Matching placebo

Cariprazine is already approved in United States for the following indications:

Approved in United States as Vraylar for:

• Schizophrenia
• Acute manic or mixed episodes associated with bipolar I disorder
• Depressive episodes associated with bipolar I disorder (bipolar depression)
• Adjunctive treatment with an antidepressant therapy (ADT) for major depressive disorder (MDD)

Who Is Running the Clinical Trial?

The Medical Research Network

Lead Sponsor

Trials

6

Recruited

310+

AbbVie

Industry Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Findings from Research

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]

References

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

Mirtazapine treatment of social phobia in women: a randomized, double-blind, placebo-controlled study. [2019]

2. England pubmed.ncbi.nlm.nih.gov

A review of 19 double-blind placebo-controlled studies in social anxiety disorder (social phobia). [2022]

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

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

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

A 12-Week Double-Blind, Placebo-Controlled, Flexible-Dose Trial of Vilazodone in Generalized Social Anxiety Disorder. [2018]

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

Nefazodone for social phobia: a clinical case series. [2018]