Cariprazine for Social Anxiety Disorder (SAD)

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
The Medical Research Network, LLC, New York, NY
Social Anxiety Disorder (SAD)+3 More
Cariprazine - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The proposed study is a 12 week double-blind, placebo-controlled trial to examine the efficacy, safety, and tolerability of Vraylar® (cariprazine) in the treatment of patients with Social Anxiety Disorder (SAD), as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5). Subjects will be randomized to one of two treatment arms (placebo or Vraylar® 1.5 mg/day) in a 1:1 ratio. The study will be done at a single clinical research site.

Eligible Conditions

  • Social Anxiety Disorder (SAD)

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Social Anxiety Disorder (SAD)

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 12 Weeks or LOCF

12 Weeks or LOCF
Change in LSAS Score

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Social Anxiety Disorder (SAD)

Side Effects for

Cariprazine (6-12 mg/Day)
22%Akathisia
12%Headache
11%Nausea
11%Constipation
10%Insomnia
8%Vomiting
7%Extrapyramidal disorder
6%Dyspepsia
6%Restlessness
6%Tremor
5%Diarrhoea
4%Dizziness
2%Mania
1%Bipolar I disorder
1%Depression
0%Bipolar disorder
0%Aggression
0%Endometrial cancer
0%Hospitalisation
0%Pulmonary embolism
This histogram enumerates side effects from a completed 2011 Phase 3 trial (NCT01058668) in the Cariprazine (6-12 mg/Day) ARM group. Side effects include: Akathisia with 22%, Headache with 12%, Nausea with 11%, Constipation with 11%, Insomnia with 10%.

Trial Design

2 Treatment Groups

Cariprazine
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

40 Total Participants · 2 Treatment Groups

Primary Treatment: Cariprazine · Has Placebo Group · Phase 4

Cariprazine
Drug
Experimental Group · 1 Intervention: Cariprazine · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cariprazine
2010
Completed Phase 3
~11060

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks or locf
Closest Location: The Medical Research Network, LLC · New York, NY
Photo of New York  1Photo of New York  2Photo of New York  3
2008First Recorded Clinical Trial
5 TrialsResearching Social Anxiety Disorder (SAD)
40 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Subjects must be sexually active and must be willing to use an effective form of contraception for the duration of the trial and for at least 4 weeks after it ends.
Subjects must have a minimum total score of 70 on the LSAS at both Screening and Baseline visits.
You are male or female, and you are between 18 and 65 years of age.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.