Phase
Condition
Mood Disorders
Tourette's Syndrome
Psychosis
Treatment
Brexpiprazole
Aripiprazole
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Provide written informed consent form by subjects and subject's legal guardian orlegally acceptable representative.
The subjects and subject's legal guardian or legally acceptable representative havethe ability to understand the nature of the trial, agree to comply with theprescribed medication and dosage regimens, complete the scheduled visits, report theadverse events and concomitant medication to investigators, and to be reliably ratedon psychiatrically scales.
At the time of signing informed consent, 18 ≤ age of the subject ≤ 65.
Subjects who are diagnosed with schizophrenia according to Diagnostic andStatistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)and confirmed by Mini International Neuropsychiatric Interview (MINI).
Subjects who are experiencing an acute exacerbation of psychotic symptoms and markeddeterioration of usual function as demonstrated by meeting ALL of the followingcriteria at the screening and baseline visit:
● PANSS total score ≥ 70;
- Score ≥ 4 on at least 2 of the following PANSS items :
( P2 Conceptual disorganization, P3 Hallucinatory behavior, P6 Suspiciousness /persecution, G9 Unusual thought content ) ● CGI-S score ≥ 4;
- Subjects willing to discontinue all prohibited psychotropic medications to meetprotocol-required washouts prior to and during the trial period.
Exclusion
Exclusion Criteria:
From ICF to 30 days after the last dose, females of childbearing potential and malesubjects who are not willing or cannot practice contraceptive methods.
Females who are pregnant or breastfeeding.
Subjects who have been hospitalized for > 21 days for the current acute episode atthe time of the Baseline visit, excluding hospitalization for psychosocial reasons.
Subjects with improvement of ≥ 30% in total PANSS score between the screening andbaseline assessment. Improvement in PANSS score= (score at screening-score atbaseline)/ (score at screening-30)*100%.
Subjects with schizophrenia who are considered resistant/refractory to antipsychotictreatment by history of failure to respond to 2 adequate different antipsychoticmedications with a minimum of 6 weeks at clinically efficacious tolerated doses.Subjects who have a systemic treatment of clozapine.
Subjects with a current DSM-IV-TR Axis I diagnosis (including but not limited to):schizoaffective disorder, MDD, bipolar disorder, post-traumatic stress disorder,anxiety disorders, delirium, dementia, amnestic or other cognitive disorders.
Subjects with a current DSM-IV-TR Axis II diagnosis: borderline, paranoid,histrionic, schizotypal, schizoid, or antisocial personality disorders.
Subjects who present a serious risk of suicide:
● Subjects who answer "Yes" on the C-SSRS Suicidal Ideation Item 4 or 5 and meetingthe criteria for this C-SSRS Item 4 or 5 occurred within the last 6 months; OR
● Subjects who answer "Yes" on any of the 5 C-SSRS Suicidal Behavior Items andmeeting the criteria for any of these 5 C-SSRS Suicidal Behavior Items occurredwithin the last 2 years; OR
● Subjects who, in the opinion of the investigator, present a serious risk ofsuicide
Subjects with clinically diagnosed tardive dyskinesia, as determined by a score of ≥ 3 in Item 8 of the AIMS at the Screening visit.
Subjects with a score of 5 in the BARS global clinical assessment of akathisia atScreening or Baseline.
Subjects who have met DSM-IV-TR criteria for substance abuse or dependence withinthe 180 days prior to Screening Visit; including alcohol and benzodiazepines, butexcluding caffeine and nicotine.
Subjects with uncontrolled thyroid disease and/or abnormal free thyroxine (FT4)examination results at Screening, unless it has been confirmed by the investigatorthat the condition has been stabilized by medication > 90 days before screening
Subjects with type I diabetes or uncontrolled type II diabetes. Subjects with typeII diabetes may be eligible for the trial if their condition is stable as determinedby satisfying ALL of the following criteria:
HbA1c < 7.0%, AND
Glucose must be ≤ 125 mg/dL or ≤ 6.94 mmol/L (fasting) or < 200 mg/dL or < 11.1mmol/L (non-fasting) at Screening. If the non-fasting glucose is ≥ 200 mg/dL or ≥ 11.1 mmol/L, subjects must be retested in a fasted state and the retest valuemust be ≤ 125 mg/dL or ≤ 6.94 mmol/L, AND
Subjects have maintained a stable regimen of oral anti-diabetic medication(s)for at least 28 days prior to screening or diabetes has been well-controlled bydiet for at least 28 days prior to screening, AND
Subjects have not had any hospitalizations within the 12 months prior toscreening due to diabetes or complications related to diabetes, AND
Subjects whose diabetes is not newly diagnosed during screening for the trial.
Subjects with uncontrolled hypertension (diastolic blood pressure > 95 mmHg in anyposition) or symptomatic hypotension, or orthostatic hypotension which is defined asa decrease of ≥ 30 mmHg in systolic blood pressure and/or a decrease of ≥ 20 mmHg indiastolic blood pressure after at least 3 minutes standing compared to the previoussupine blood pressure, OR development of symptoms.
Subjects with a history of ischemic heart disease or history of myocardialinfarction, congestive heart failure (whether controlled or uncontrolled),angioplasty, stenting, or coronary artery bypass surgery.
Subjects who have a history or severe organic disease of vital organs (including butnot limited to hepatic, renal, respiratory, cardiovascular, endocrine, neurologic,hematologic, or immunologic disease).
Subjects with epilepsy or a history of seizures, except for a single seizureepisode, for instance childhood febrile seizure and post traumatic or alcoholwithdrawal.
The following laboratory test and ECG results are exclusionary:
- Platelets ≤ 75,000/mm3 (≤ 75 x 109 /L) 2) Hemoglobin ≤ 9 g/dL (90 g/L) 3)Neutrophils ≤ 1,000/mm3 (1 x 109 /L) 4) AST or ALT > 2 × ULN 5) CPK > 3 × ULN 6)Creatinine ≥ 2 mg/dL (176.8 µmol/L) 7) HbA1c ≥ 7.0% 8) QTc ≥ 450 msec (for males) or ≥ 470 msec (for females) in ECG 19. Subjects who received ECT within 60 days ofscreening. 20. Subjects with a history of neuroleptic malignant syndrome (NMS). 21.Subjects with a history of true allergic response (ie, not intolerance) to more thanone class of medications.
Subjects who participated in a clinical trial within the last 90 days or whoparticipated in two or more clinical trials within the past year.
Any subject who, in the opinion of the investigator, should not participate in thetrial.
Study Design
Study Description
Connect with a study center
No.15 Yanyin Road, Yanta District
Xi'an, Shanxi 710061
ChinaSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.