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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

Study Summary

This trial will test whether Vraylar® is an effective, safe, and tolerable treatment for Social Anxiety Disorder. Subjects will be randomly assigned to either take Vraylar® or a placebo for 12 weeks. The study will be conducted at a single clinical research site.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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%
Aggression
1%
Hospitalisation
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)

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?

AbbVieIndustry Sponsor
946 Previous Clinical Trials
496,432 Total Patients Enrolled
The Medical Research NetworkLead Sponsor
5 Previous Clinical Trials
270 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: Placebo, Cariprazine
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the current trial still accepting new participants?

"Clinicaltrials.gov states that this clinical trial is not actively recruiting, although it was initially posted on July 15th 2022 and edited most recently on May 17th 2022. However, there are 1227 other medical trials presently seeking patient participants."

Answered by AI

Who is the ideal demographic for this research trial?

"This study is actively seeking 40 people with social phobia aged 18 to 65. In order for a participant to be approved, they must comply with the following prerequisites: commit to an effective form of contraception during and up to 4 weeks after the trial ends (condoms, diaphragm etc.), provide written informed consent beforehand; be diagnosed via psychiatric evaluation as having Social anxiety Disorder according DSM-5 criteria and confirmed by Mini International Neuropsychiatric Interview; have total Liebowitz Social Anxiety Scale score of 70 at Screening & Baseline visits; possess Hamilton Depression Rating Scale scores less than 16 respectively on these same dates; present Clinical"

Answered by AI

What potential side effects should patients be aware of when taking Cariprazine?

"Cariprazine has already been approved, thus earning a score of 3 in terms of safety."

Answered by AI

Can octogenarians participate in this research?

"This trial is only open to individuals aged between 18 and 65. However, there exist 326 medical studies that cater for those below the age of consent and 822 experiments aimed at people above the traditional retirement age."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
The Medical Research Network, LLC
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

So I can find something that will work for my social anxiety.
PatientReceived 2+ prior treatments
~15 spots leftby Mar 2025