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Atypical Antipsychotic

Iloperidone for Bipolar Disorder

Phase 3
Waitlist Available
Research Sponsored by Vanda Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with bipolar I disorder, manic or mixed-type, per DSM-5 criteria
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
Approved for 5 Other Conditions

Study Summary

This trial will compare the effectiveness of iloperidone versus placebo in treating people with acute manic or mixed episodes associated with Bipolar I Disorder.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with bipolar I disorder, which causes episodes of extreme mood swings between mania and depression.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4 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 from Baseline in Young Mania Rating Scale (YMRS) total score

Side effects data

From 2014 Phase 4 trial • 20 Patients • NCT01464229
46%
Dry Mouth
15%
Nausea
15%
Somnolence
15%
Headaches
8%
Palpitations
8%
Cramping
8%
Increased Irritability
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Iloperidone

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: IloperidoneExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Iloperidone
FDA approved

Find a Location

Who is running the clinical trial?

Vanda PharmaceuticalsLead Sponsor
59 Previous Clinical Trials
23,691 Total Patients Enrolled
1 Trials studying Bipolar Disorder
41 Patients Enrolled for Bipolar Disorder

Frequently Asked Questions

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

Are there still positions available for volunteers in this trial?

"This trial, which was originally posted on 3/22/2021 and last edited on 3/24/2021, is currently searching for participants, as reported on clinicaltrials.gov."

Answered by AI

How many people are eligible to join this clinical trial?

"That is correct. The clinicaltrials.gov website lists this trial as actively recruiting patients. The trial was first posted on March 22, 2021 and was last updated on March 24, 2021. The study is looking for 400 patients from 3 different sites."

Answered by AI

Has the government given its okay to sell Iloperidone?

"Iloperidone's Phase 3 status indicates that, while more data is needed to confirm efficacy, there is enough evidence of safety from multiple rounds of testing. Therefore, it received a score of 3."

Answered by AI

How can patients become eligible for this program?

"400 individuals will be admitted into this study that aims to test the efficacy of a new treatment for bipolar I disorder. The age requirements for participants are between 18 and 65 years old."

Answered by AI

Does this research include test subjects that are in their seventies?

"The age restrictions for this trial are that participants must have celebrated their 18th birthday, and have not yet reached their 65th birthday."

Answered by AI

Could you please outline the other scientific research projects that have used Iloperidone?

"There are currently two ongoing clinical trials studying iloperidone, both of which are in Phase 3. 4 medical facilities in total are conducting research on iloperidone, with a few based in Atlanta, Georgia."

Answered by AI

What other similar trials have been attempted in the past?

"As of now, there are two ongoing studies involving iloperidone in 4 cities across 2 nations. The first recorded trial was completed in 2013 and involved 288 patients. That study reached Phase 3 approval and was sponsored by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. In the 7 years since the first study, 14 more iloperidone trials have been completed."

Answered by AI

Who else is applying?

What state do they live in?
California
Utah
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
Vanda Investigational Site
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

How responsive is this trial?

Most responsive sites:
  1. Vanda Investigational Site: < 24 hours
Typically responds via
Phone Call
Average response time
  • < 1 Day
~106 spots leftby Feb 2025