A clinical study to evaluate iloperidone in the treatment of patients with acute manic episodes associated with Bipolar I Disorder
- Conditions
- Acute manic episodes associated with Bipolar I DisorderMedDRA version: 20.0Level: PTClassification code 10004939Term: Bipolar I disorderSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2020-000405-83-PL
- Lead Sponsor
- Vanda Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
Each patient must meet the following criteria for inclusion in the study:
1. Patients must provide written informed consent (IC) before any assessment is performed. Additionally, if a patient is not mentally stable to provide consent their legal guardian must also sign the inform consent form in accordance with the regulatory requirements for their respective country.
2. Males or non-fecund females (i.e., surgically sterilized, if procedure was done 6 months before screening or patient is postmenopausal, without menses for 12 months before screening), or females of childbearing potential using adequate contraception from 1 month prior to randomization through 1 month after the last dose of study medication.
Note: Examples of acceptable methods of contraception for females include the use of 2 independent barrier methods, hormonal contraception plus 1 barrier method, or surgically sterilized partner.
3. Patients must be 18 through 65 years of age inclusive.
4. Patients with Body Mass Index (BMI) of >18 and < 40 kg/m2 (BMI = weight (kg)/ [height (m)]2).
5. Patients must be cooperative, able to ingest oral medication, willing to take iloperidone or placebo, and willing to complete all aspects of the study, including hospitalizations.
6. Patients must meet the Diagnostic and Statistical Manual of Mental Disorder, Fifth Edition (DSM-5) diagnosis of bipolar I disorder, manic or mixed type, as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (SCID) manic or mixed type with or without psychotic symptoms and have had the diagnosis for at least one year.
7. Patients must have had at least one prior documented manic or mixed episode (with or without psychotic symptoms) that required treatment prior to screening.
8. Patients must have a Clinical Global Impressions of Severity (CGI-S) – Severity of Illness (Mania) score of at least 4 at baseline.
9. Patients must have a Young Mania Rating Scale (YMRS) total score =20 at screening and baseline.
10. Patients must have = 4 on at least 2 of 4 YMRS items (irritability, speech, content, disruptive/aggressive behavior).
11. Patients must have a Montgomery-Asberg Depression Rating Scale (MADRS) total score < 18.
12. Patients must be voluntarily hospitalized for current manic episode.
13. Patients must have no medical contraindication for oral treatment with iloperidone as confirmed by medical history, physical examination, electrocardiogram (ECG), and clinical laboratory tests, which are all within the normal range, or, if abnormal, judged not to be clinically significant by the principal Investigator.
A patient is eligible for enrollment into the Long-Term Open-Label Phase of this study if he/she meets the following criteria:
• Completes the Short-Term Double-Blind Phase through Day 28.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 360
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
1 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 6 m.
2 Patients with diagnosis or history suggestive of chemical dependence according to DSM-5 criteria, or toxic psychosis in the preceding 6 m., or a clinical presentation possibly confounded by the use of recreational drugs or alcohol
3 Patients experiencing a first manic episode or meeting criteria for rapid cycling
4 Patients who are mentally disabled (moderate to severe) and cannot understand the IC or participate fully in the assessments.
5 Patients with a significant brain trauma or a coma lasting more than 24 h.
6 Patients who are currently at imminent risk of harm to self or others
7 Patients with a positive urine drug screen (at the screening visit) for amphetamines, cocaine, PCP, benzodiazepines, or barbiturates will be excluded. If opiates are positive at screening, patients must provide sufficient evidence that they have been prescribed these medications and are taking them as prescribed. Patients must also be clinically evaluated for dependency and excluded if there is sufficient suspicion. If
benzodiazepine is positive at screening, patients may be allowed to
continue if the use is PRN. If benzodiazepine use is chronic, patients will
still need to be excluded
8 Patients known to suffer from blindness, deafness, language difficulties, or any other sensory or motor deficits that may prevent the patient from completing any of the study requirements
9 Patients who have suffered from significant physical illness in the 4w period preceding baseline will be excluded, unless the Investigator provides a rationale for including a specific patient and has approval of the Medical Monitor
10 Patients who suffer from other clinically significant medical conditions which could be expected to progress, recur, or change to such an extent that they may put the patient at special risk or bias the assessment of the clinical and the mental status of the patient to a significant degree will be excluded. This includes any nonpsychiatric coexistent disease state that has not been maintained in a stable condition for at least 3 m prior to baseline
11 Patient with known congenital long QT syndrome, Brugada syndrome, or other cardiac abnormality that would increase the risk of ventricular arrhythmia.
12 Patients who suffer from any clinically significant disease of the gastrointestinal system, liver, or kidneys, or any abnormal condition that compromises the function of these systems and could result in the possibility of altered absorption, excess accumulation, or impairment of metabolism or excretion of the study medication
13 Patients that have a clinically significant abnormal laboratory finding, which remained abnormal upon being repeated ONCE and that suggests a medical condition that would put the patient at special risk or significantly bias assessment of the patient’s clinical status
14 Patients that have one or more of the following serological results:
a Current hepatitis C infection
b A positive hepatitis B surface antigen (HbsAg)
c Elevated (> or = 1.5 times the upper lime of normal) LFTs (SGOT, SGPT, LDH, alkaline phosphate, or bilirubin) and one of the following: positive hepatitis A (HAV IgM) or positive hepatitis B core antibody (HBcAb-IgM)
15 Patients with a current diagnosis or past history of epilepsy, major head trauma, or progressive neurological disease (other than tar
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method