Bipolar I DisorderPhase 3NCT04819776

Evaluation of Efficacy and Safety of Iloperidone in the Acute Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder

A Phase 3 study testing Iloperidone in people with Bipolar I Disorder, run by Vanda Pharmaceuticals at 27 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of this study is to investigate the efficacy, safety, and tolerability of iloperidone compared with placebo in treating acute manic or mixed episodes associated with Bipolar I Disorder. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Bipolar I Disorder
What is being tested?: Iloperidone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 417 participants
Where: 27 sitesin 3 countries
Study dates: 22 Mar 2021to 16 Aug 2023
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female patients 18 to 65 years of age (inclusive)
Diagnosed with bipolar I disorder, manic or mixed-type, per DSM-5 criteria
Voluntary hospitalization for current manic episode

Who cannot join

Patients with a DSM-5 diagnosis of a psychiatric disorder other than bipolar I disorder that was the primary focus of treatment within the previous six months
Patients who are experiencing a first manic episode or meeting criteria for rapid cycling

Trial locations and contacts

27 sites in 3 countries.

Country

City, postcode or hospital

27 sites in 3 countries

United States20 sites

Vanda Investigational Site
Atlanta, Georgia, 30331
Vanda Investigational Site
Austin, Texas, 78754
Vanda Investigational Site
Cerritos, California, 90703
Vanda Investigational Site
Culver City, California, 90230
Vanda Investigational Site
Dayton, Ohio, 45417
Vanda Investigational Site
Decatur, Georgia, 30030
Vanda Investigational Site
DeSoto, Texas, 75115
Vanda Investigational Site
Flowood, Mississippi, 39232
Vanda Investigational Site
Gaithersburg, Maryland, 20877
Vanda Investigational Site
Las Vegas, Nevada, 89102
Vanda Investigational Site
Little Rock, Arkansas, 72211
Vanda Investigational Site
Long Beach, California, 90806
Vanda Investigational Site
Marlton, New Jersey, 08053
Vanda Investigational Site
Miami Lakes, Florida, 33016
Vanda Investigational Site
North Canton, Ohio, 44720
Vanda Investigational Site
Oakland Park, Florida, 33334
Vanda Investigational Site
Orange, California, 92868
Vanda Investigational Site
Richardson, Texas, 75080
Vanda Investigational Site
Rogers, Arkansas, 72758
Vanda Investigational Site
Torrance, California, 90502

Other trials in United States

Bulgaria6 sites

Vanda Investigational Site
Kardzhali, 6600
Vanda Investigational Site
Lovech, 5500
Vanda Investigational Site
Novi Iskar, Sofia-Grad, 1282
Vanda Investigational Site
Tserova Koria, Veliko Tarnovo, 5047
Vanda Investigational Site
Veliko Tarnovo, 5000
Vanda Investigational Site
Vratsa, 3001

Other trials in Bulgaria

Poland1 site

Vanda Investigational Site
Tuszyn, 95-080

Other trials in Poland

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Iloperidone for 4 Weeks in the Treatment of Patients With Acute Manic Episodes Associated With Bipolar I Disorder

The aim of this study is to investigate the efficacy, safety, and tolerability of iloperidone compared with placebo in treating acute manic or mixed episodes associated with Bipolar I Disorder.

Conditions: Bipolar I Disorder
Being tested: Iloperidone, Iloperidone Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IloperidoneDrug
Also called FANAPT®, VYV-683
Oral iloperidone
Iloperidone PlaceboDrug
Oral placebo

Study groups in NCT04819776
Study group	Role	What they receive
Iloperidone	Experimental	Not described Receives: Drug: Iloperidone
Placebo	Placebo comparator	Not described Receives: Drug: Iloperidone Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline to Week 4 in Young Mania Rating Scale (YMRS) Total Score
The Young Mania Rating Scale (YMRS) is an 11-item scale. Individual item scores are summed for a total possible score of 0 (best) to 60 (worst).
Measured: Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Mar 202116 Aug 2023

First posted29 Mar 2021
Study start22 Mar 2021
Primary completion7 Sep 2022
Study completion16 Aug 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Bipolar I DisorderStudies of the same condition, open and under way.
More trials run by Vanda PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 417 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04819776
Sponsor's protocol ID: VP-VYV-683-3201
Status last verified: Apr 2024
First submitted: 24 Mar 2021
Last updated: 18 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Torres R, Czeisler EL, Chadwick SR, Stahl SM, Smieszek SP, Xiao C, Polymeropoulos CM, Birznieks G, Polymeropoulos MH. Efficacy and Safety of Iloperidone in Bipolar Mania: A Double-Blind, Placebo-Controlled Study. J Clin Psychiatry. 2024 Jan 15;85(1):23m14966. doi: 10.4088/JCP.23m14966.
PubMed 38236020

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Bipolar I Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Iloperidone for 4 Weeks in the Treatment of Patients With Acute Manic Episodes Associated With Bipolar I Disorder
ClinicalTrials.gov ID: NCT04819776
Acronym / sponsor ID: VP-VYV-683-3201
Conditions: Bipolar I Disorder
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 417 participants (actual)
Lead sponsor: Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 22 Mar 2021 (actual)
Primary completion: 7 Sep 2022 (actual)
Study completion: 16 Aug 2023 (actual)
First posted: 29 Mar 2021 (actual)
Results: Posted 16 Apr 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The aim of this study is to investigate the efficacy, safety, and tolerability of iloperidone compared with placebo in treating acute manic or mixed episodes associated with Bipolar I Disorder.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Iloperidone	Experimental	Drug: Iloperidone
Placebo	Placebo comparator	Drug: Iloperidone Placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Male or female patients 18 to 65 years of age (inclusive)
Diagnosed with bipolar I disorder, manic or mixed-type, per DSM-5 criteria
Voluntary hospitalization for current manic episode

Key exclusion criteria (2 listed)

Patients with a DSM-5 diagnosis of a psychiatric disorder other than bipolar I disorder that was the primary focus of treatment within the previous six months
Patients who are experiencing a first manic episode or meeting criteria for rapid cycling

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IloperidoneAlso: FANAPT®, VYV-683Oral iloperidone	Drug	Iloperidone
Iloperidone PlaceboOral placebo	Drug	Placebo

Primary outcome

Change From Baseline to Week 4 in Young Mania Rating Scale (YMRS) Total Score
Time frame: Week 4
The Young Mania Rating Scale (YMRS) is an 11-item scale. Individual item scores are summed for a total possible score of 0 (best) to 60 (worst).

Results and safety

Results posted to the registry on 16 Apr 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Iloperidone	206	139
Placebo	208	153

Primary outcome: Change From Baseline to Week 4 in Young Mania Rating Scale (YMRS) Total Score

Time frame: Week 4. Mean (Standard Error). Unit: Change from Baseline in YMRS Total Score

Measure	Iloperidone n = 198	Placebo n = 194
Value	-14.0 (0.64)	-10.0 (0.63)

Population analysed: Efficacy analyses were based on the Intent-To-Treat (ITT) population, which included all randomized patients who received a dose of study drug and had at least one valid post-baseline efficacy measurement while on study medication. Of the 417 randomized, 392 received at least one dose of study medication and had at least one valid post-baseline efficacy measurement.

Adverse events

Time frame: AE data was collected during the 28 day study period plus a 7 day follow up period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Iloperidone	4 of 206 (1.9%)	88 of 206 (42.7%)	0 of 206
Placebo	1 of 208 (0.5%)	25 of 208 (12%)	0 of 208

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38236020Torres R, Czeisler EL, Chadwick SR, Stahl SM, Smieszek SP, Xiao C, Polymeropoulos CM, Birznieks G, Polymeropoulos MH. Efficacy and Safety of Iloperidone in Bipolar Mania: A Double-Blind, Placebo-Controlled Study. J Clin Psychiatry. 2024 Jan 15;85(1):23m14966. doi: 10.4088/JCP.23m14966.

Related trials for Bipolar I Disorder

Recruiting
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Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
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RecruitingPhase 3
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RecruitingPhase 3
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
Bipolar Depression

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

27 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Iloperidone in people with Bipolar I Disorder, run by Vanda Pharmaceuticals at 27 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, Bulgaria, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Week 4 in Young Mania Rating Scale (YMRS) Total Score (time frame: Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04819776, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.