Cariprazine for Social Anxiety Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the effectiveness and safety of Vraylar® (cariprazine) for treating Social Anxiety Disorder (SAD), a condition that makes social interactions very stressful. Participants will receive either the medication or a placebo (a harmless pill with no active drug) to compare results. It is ideal for adults diagnosed with SAD who feel it affects their daily life but do not have other major mental health issues like schizophrenia or bipolar disorder. As a Phase 4 trial, this research seeks to understand how this already FDA-approved and effective treatment benefits more patients.
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.
What is the safety track record for Cariprazine?
Research has shown that cariprazine is generally safe and well-tolerated. In various studies, a high percentage of participants completed their treatment. For instance, 78% and 82% of participants finished their treatment in different dose studies, indicating that most did not experience severe side effects.
In some studies on bipolar conditions, a small number of patients (1% to 3%) reported suicidal thoughts. However, this is a rare occurrence, highlighting the treatment's usual tolerability. Overall, evidence suggests that cariprazine is a promising option with manageable safety concerns for many patients.12345Why are researchers enthusiastic about this study treatment?
Cariprazine is unique because it offers a new approach to treating social anxiety disorder by targeting dopamine D3 and D2 receptors with a preference for D3. Most current treatments for social anxiety, like SSRIs and SNRIs, focus on serotonin and norepinephrine pathways. By acting on dopamine receptors, cariprazine might provide relief for those who haven't responded well to traditional options. Researchers are excited about its potential to address symptoms more effectively and quickly, offering hope for better management of social anxiety.
What evidence suggests that this trial's treatments could be effective for Social Anxiety Disorder?
Research has shown that cariprazine, known as Vraylar®, effectively treats mental health issues such as major depressive disorder. Studies indicate that cariprazine can significantly reduce depression symptoms, suggesting potential benefits for Social Anxiety Disorder (SAD) as well. In animal studies, cariprazine improved social behaviors, hinting at its usefulness for social anxiety. In this trial, participants will receive cariprazine at doses between 1.5 mg and 3 mg per day, which is expected to help manage SAD symptoms based on positive results in similar conditions.12678
Who Is on the Research Team?
Michael R Liebowitz, MD
Principal Investigator
Managing Director
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Cariprazine or placebo for Social Anxiety Disorder in a double-blind, placebo-controlled trial
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cariprazine
- Placebo
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Cariprazine 1.5 to 3 mg per day
Matching placebo
Cariprazine is already approved in United States for the following indications:
- 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)
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Medical Research Network
Lead Sponsor
AbbVie
Industry Sponsor
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
Published Research Related to This Trial
Citations
Cariprazine's Potential in Improving Social Dysfunction in ...
Finally, in animal research only cariprazine was found to be effective in the social play paradigm when compared to other SGAs (64).
2.
centerwatch.com
centerwatch.com/clinical-trials/listings/NCT05384483/cariprazine-versus-placebo-for-social-anxiety-disorderCariprazine Versus Placebo for Social Anxiety Disorder
The proposed study is a 12 week double-blind, placebo-controlled trial to examine the efficacy, safety, and tolerability of Vraylar® ...
Clinical Review - Cariprazine (Vraylar) - NCBI - NIH
The response rate among patients receiving placebo ranged from 32% to 40% across the trials. The benefit of treatment with cariprazine (1.5 mg and 3.0 mg) was ...
Real-world effectiveness of cariprazine in major depressive ...
The RCT results demonstrated a significant reduction in mean MADRS total score after 6 or 8 weeks of cariprazine treatment. Further, a post hoc analysis of the ...
Trial | NCT05384483
The proposed study is a 12 week double-blind, placebo-controlled trial to examine the efficacy, safety, and tolerability of Vraylar® (cariprazine) in the ...
A pooled post hoc analysis evaluating the safety and ...
Cariprazine was generally safe and well tolerated; study completion rates were 78% and 82% in the modal dose and fixed-dose analyses, ...
Cariprazine Versus Placebo for Social Anxiety Disorder
The proposed study is a 12 week double-blind, placebo-controlled trial to examine the efficacy, safety, and tolerability of Vraylar® ...
May 23, 2022
Patients treated with cariprazine at 3.0 mg/day demonstrated improvement in MADRS total score at week six compared to placebo but did not meet ...
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