Study of the efficacy of brexpiprazole on comorbid social anxiety symptoms in schizophrenia

JRCT ID: jRCTs031200258

Registered date:21/12/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Schizophrenia, schizoaffective disorder
• Date of first enrollment: 04/08/2021
• Target sample size: 50
• Study type: Interventional

Intervention(s)

Period 1: 12 weeks (brexpiprazole treatment including switching period within 8 weeks).
<Switching method>
After the addition of brexpiprazole to prior antipsychotics, the dose of prior antipsychotics will be reduced and the prior antipsychotics will be switched to brexpiprazole.
Brexpiprazole is administered orally once daily, starting at 1 mg/day and allowing the dose to be increased from 5 days to 2 mg/day.
The dosage and administration of previous antipsychotics will not be changed until at least 2 weeks after the start of brexpiprazole treatment. After this period, the previous antipsychotics will be tapered and discontinued within 8 weeks after the start of brexpiprazole treatment.

Period 2 : 12 weeks (Week 12 to Week 24)
Treatment with brexpiprazole 1-2 mg/day will be continued.

Outcome(s)

• Primary Outcome: Change from baseline in LSAS-J at Week 12 after initiation of brexpiprazole, excluding use of restricted concomitant medications

Secondary Outcome

1. Change from baseline in LSAS-J at 12 weeks after initiation of brexpiprazole, including use of restricted concomitant medications
2. Changes from baseline in LSAS-J at Weeks 4, 8, and 24/Final Assessment Time after initiation of brexpiprazole administration
3. Change from baseline in WHO-QOL 26 at Weeks 12 and 24/Final Assessment Time after initiation of brexpiprazole administration
4. Change from baseline in Social Functioning Scale Japanese version (SFS-J) at Weeks 12 and 24/Final Assessment Time after initiation of brexpiprazole administration
5. Change from Baseline in the Brief assessment of cognition in schizophrenia Japanese version (BACS-J) composite Scores at Weeks 24/Final Assessment Time after initiation of brexpiprazole administration

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 50age old
• Gender: Both

Include criteria

(1)Patients diagnosed with schizophrenia or schizoaffective disorder in DSM-5
(2)Patients with social anxiety symptoms with Liebowitz Social Anxiety Scale Japanese version (LSAS-J) scores of 50 or more (*).
* Both at screening and at the start of brexpiprazole treatment
(3)Patients who wish to improve symptoms of social anxiety or who are expected to be treated by an investigator
(4)A patient who has the ability to give informed consent and can give written informed consent from the patient. Patients in whom written informed consent is obtained from the person and the legally acceptable representative for minor patients (Ages 18 and 19 as of the date of informed consent)
(5)Outpatients with stable (*) psychotic symptoms
* Definition Stability:
Patients who have no history of hospitalization in the past 180 days from the date of informed consent, have a certain dose of antipsychotic drugs in the past 28 days from the date of informed consent, have no psychotic symptoms of acute exacerbation, and have not changed the dose of antipsychotic drugs or other psychotropic drugs between the date of informed consent and the start of brexpiprazole.
(6)Male and female patients aged 18-50 years on the date of informed consent
(7)Patients with a chlorpromazine (CP) equivalent of 150-800 mg/day on the previous treatment antipsychotics in the 28 days prior to the date of informed consent.
(8)Patients with a CP-equivalent dose of 800 mg/day or less on all pretreatment antipsychotics on the date of informed consent.

Exclude criteria

(1)Pregnant women, patients scheduled for pregnancy
(2)Patients with a history of clozapine use
(3)Patients with acute exacerbation of psychotic symptoms
(4)Patients who had received antidepressant treatment within 28 days before the date of informed consent
(5)Patients with premorbid IQs less than 70 as estimated by the Brief Assessment of Intellectual Functioning (JART)
(6)Patients with an international normalized HbA1c of 6.5% (JDS 6.1%) or higher at the time of the screening test
(7)Patients with clinically significant diseases of the nervous system, liver (moderate to severe hepatic impairment (Child-Pugh class B or C)), kidneys, metabolic system, blood system, immune system, cardiovascular system, lungs, or digestive system. However, patients may be enrolled if their condition is minimal or well controlled and the evaluation of safety and efficacy is not considered to be impeding.
(8)Patients with the following laboratory values at the time of the screening test
1. Platelet count <= 75000/mm3 (/microliter)
2. Hemoglobin <= 9 g/dL
3. Absolute neutrophils <= 1000/mm3
4. AST > 2 times the upper limit of normal
5. ALT > 2 times the upper limit of normal
6. CPK > 3 times the upper limit of normal
7. Creatinine >= 2 mg/dL
(9)Patients who used aripiprazole within 28 days before obtaining informed consent
(10)Patients who developed acute depressive symptoms within 28 days before obtaining informed consent and were judged to require treatment with antidepressants
(11)Patients who received electroconvulsive therapy (ECT) within 60 days before obtaining informed consent
(12)Patients who are being treated with long-acting antipsychotics within 90 days before informed consent is obtained
(13)Patients hospitalized for psychotic symptoms within 180 days before obtaining informed consent
(14)Patients who are classified as having substance abuse or substance dependence, including alcohol and benzodiazepines, within 180 days before obtaining informed consent
(15)Patients who have shown suicidal ideation within 180 days before obtaining informed consent, suicidal behavior within the last 2 years, or who are judged to be at high risk of suicide
(16)Patient with a contraindication of brexpiprazole
1. Patient in coma
2. Patients under strong influence of barbiturates and central nervous system depressants such as anesthetics
3. Patients receiving adrenaline
4. Patients with a history of hypersensitivity to components of brexpiprazole
(17)Patients for whom the investigator or subinvestigator judges it inappropriate to perform the study safely
(18)Patients who participated in OPC-34712 clinical trials
(19)Patients with a history of brexpiprazole use

Related Information

• Primary Sponsor: Nemoto Takahiro
• Secondary Sponsor: Otsuka Pharmaceutical Co., Ltd.