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Atypical Antipsychotic

Cariprazine for Social Anxiety Disorder

Phase 4
Waitlist Available
Led By Michael R Liebowitz, MD
Research Sponsored by The Medical Research Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks or locf
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved

Summary

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.

Eligible Conditions
  • Social Anxiety Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks or locf
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks or locf for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in LSAS Score

Side effects data

From 2011 Phase 3 trial • 497 Patients • NCT01058668
17%
Akathisia
11%
Headache
10%
Nausea
10%
Extrapyramidal disorder
10%
Insomnia
9%
Vomiting
9%
Restlessness
5%
Constipation
5%
Dizziness
4%
Dyspepsia
2%
Mania
2%
Diarrhoea
2%
Tremor
1%
Hospitalisation
1%
Aggression
1%
Bipolar disorder
1%
Endometrial cancer
1%
Pulmonary embolism
1%
Bipolar I disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Cariprazine (3-6 mg/Day)
Cariprazine (6-12 mg/Day)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CariprazineExperimental Treatment1 Intervention
Cariprazine 1.5 to 3 mg per day
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cariprazine
2010
Completed Phase 3
~11050

Find a Location

Who is running the clinical trial?

The Medical Research NetworkLead Sponsor
5 Previous Clinical Trials
270 Total Patients Enrolled
AbbVieIndustry Sponsor
1,023 Previous Clinical Trials
520,249 Total Patients Enrolled
Michael R Liebowitz, MDPrincipal InvestigatorManaging Director
1 Previous Clinical Trials
30 Total Patients Enrolled

Media Library

Cariprazine (Atypical Antipsychotic) Clinical Trial Eligibility Overview. Trial Name: NCT05384483 — Phase 4
Social Anxiety Disorder Research Study Groups: Cariprazine, Placebo
Social Anxiety Disorder Clinical Trial 2023: Cariprazine Highlights & Side Effects. Trial Name: NCT05384483 — Phase 4
Cariprazine (Atypical Antipsychotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05384483 — Phase 4
~12 spots leftby Nov 2025
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