Cariprazine for Social Anxiety Disorder (SAD)
Phase-Based Progress Estimates
Effectiveness
Safety
The Medical Research Network, LLC, New York, NY
Social Anxiety Disorder (SAD)+3 More
Cariprazine - DrugEligibility
18+
All Sexes
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Eligibility
18+
All Sexes
What conditions do you have?
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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
This is further along than 93% of similar trials
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: 12 Weeks or LOCF
12 Weeks or LOCF
Change in LSAS Score
Trial Safety
Safety Progress
This is further along than 85% of similar trials
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
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: DrugPlacebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTreatment
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
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 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.
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