Iloperidone for Disease

Phase-Based Estimates
2
Effectiveness
3
Safety
Vanda Investigational Site, Marlton, NJ
Disease+1 More
Iloperidone - Drug
Eligibility
18+
All Sexes
Eligible conditions
Disease

Study Summary

This study is evaluating whether a drug may help treat bipolar disorder.

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Eligible Conditions

  • Disease
  • Bipolar I Disorder

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Compared to trials

Study Objectives

This trial is evaluating whether Iloperidone will improve 1 primary outcome in patients with Disease. Measurement will happen over the course of Week 4.

Week 4
Change from Baseline in Young Mania Rating Scale (YMRS) total score

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Compared to trials

Side Effects for

Iloperidone
Dry Mouth
46%
Headaches
15%
Somnolence
15%
Nausea
15%
Palpitations
8%
Increased Irritability
8%
Cramping
8%
This histogram enumerates side effects from a completed 2014 Phase 4 trial (NCT01464229) in the Iloperidone ARM group. Side effects include: Dry Mouth with 46%, Headaches with 15%, Somnolence with 15%, Nausea with 15%, Palpitations with 8%.

Trial Design

2 Treatment Groups

Placebo
Iloperidone
Placebo group

This trial requires 400 total participants across 2 different treatment groups

This trial involves 2 different treatments. Iloperidone is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Iloperidone
Drug
Placebo
Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Iloperidone
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 4
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly week 4 for reporting.

Closest Location

Vanda Investigational Site - Marlton, NJ

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
I need to be hospitalized for my current manic episode. show original
The person has been diagnosed with bipolar I disorder, which is a mental illness characterized by extreme mood swings show original
Male or female patients 18 to 65 years of age (inclusive)

Patient Q&A Section

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

Does disease run in families?

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The association of premature ovarian failure with early and delayed menopause and of ovarian and [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) with early menopause is consistent with an additive risk for premature ovarian failure and of pre- and postclinically diagnosed breast and ovarian cancer.

Unverified Answer

Who should consider clinical trials for disease?

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To increase the number of candidates who enroll in clinical trials, the health professional must take note of and provide feedback to the patient about all aspects of clinical trials. The health professional should work at educating the patients, informing them about where the trials are being held, and helping them to make the best decision possible.

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What are the signs of disease?

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There are four main findings from these studies on what are the significant medical signs that are associated with disease. First, all the signs of disease are related to pathology that is detectable clinically; this indicates that all the signs of disease are pathological.

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What is disease?

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Diseases are major drivers of the healthcare environment, affecting patients, professionals and the economy. A system of disease classification is needed as it increases understanding of disease and the way disease is treated, preventing unnecessary treatment.

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What are common treatments for disease?

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Common treatments for disease include medications for asthma, diabetes, epilepsy, hypertension, and heart disease.\n\nMany pharmaceuticals may be used in the prevention of disease, but not in treatment. Examples of this include aspirin (to prevent heart attacks), probiotics (to prevent infections), and statins (to prevent strokes).\n\nThis branch of pharmacy is concerned with pharmaceutical education and dispensing the medications that meet the various health requirements of a population to achieve the objectives of medical therapy and the practice of preventive medicine\n\nThis part of pharmacology is the study of drug metabolism. \nAn example of this field of study would be the study of the metabolism of drugs.

Unverified Answer

What causes disease?

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Chronic diseases are a consequence of the environment, genetics, and the interaction of genetics and environment. The environmental effects are a result of a complex interplay of a combination of biological, psychosocial, and environmental factors. The biological factors include individual predisposition, environmental factors such as genetics and toxic exposures, and the natural history of disease.

Unverified Answer

How many people get disease a year in the United States?

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In 2018, there were approximately 926,400 new and 712,000 relapsing cases of Crohn's disease, as well as about 20,400 cases of ulcerative colitis. Additionally, around 60,000 adults are diagnosed with inflammatory neuropathies (e.g., polyradiculopathy and Guillain–Barré syndrome). Approximately 7,200 new cases of familial adenomatous polyposis and 2,400 new cases of Cowden syndrome are diagnosed every year in the United States. Approximately 3 million new cases of multiple endocrine neoplasia 1 occur annually, with an estimated 10% of Americans at risk.

Unverified Answer

Is iloperidone typically used in combination with any other treatments?

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Iloperidone is usually used in combination with other treatments but the combination does not affect results. Therefore, iloperidone alone may be beneficial in depressive symptoms in general. There is no evidence that this combination has greater efficacy than iloperidone monotherapy for depression of any specified demographic in the clinic. Clinical trials are ongoing to help further inform these findings, while further studies are needed on the treatment of depression and panic disorder.

Unverified Answer

Is iloperidone safe for people?

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A high proportion of patients in this study received a dosage that was higher than the recommended dosage. This led to dose escalation, which frequently resulted in more side effects than a lower dose of iloperidone. Patients taking antipsychotics should receive proper adjustment of the appropriate dose to avoid the possibility of side effects. Physicians often do not give patients enough information and guidance to take medicines correctly, resulting in some side effects, a reduced compliance rate, and an increased likelihood of non-compliance.

Unverified Answer

What is iloperidone?

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One major side effect reported in the package inserts is abdominal pain, most commonly due to delayed gastric emptying with concomitant constipation. Many patients who did not experience this symptom have the drug discontinued due to this side effect. This report suggests that the risk of side effects may be minimized by obtaining the lowest effective dose of the drug or by changing its dose regimen. For patients who require a dose escalation, iloperidone is generally well tolerated and effective with no serious side effects.

Unverified Answer

How serious can disease be?

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Individuals with a serious complication of IBD could develop chronic lung disease, COPD or cancer later in life. Complications are extremely detrimental and have a large impact on patients' quality of life.

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