Double-blind confirmatory study of AD-5423 (blonanserin) in patients with schizophrenia [Phase 3 study]

Phase 3

• Conditions: schizophrenia

• Registration Number: JPRN-jRCT2080220098
• Lead Sponsor: Dainippon Sumitomo Pharma Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

[Major inclusion criteria]
1) Patients with schizophrenia who are classified as F.20 in the ICD 10 Diagnostic Criteria for Research (DCR 10)
2) Patients aged 15 years or older
3) Either male or female
4) Either inpatients or outpatients
5) Patients who have given written informed consent

[Major exclusion criteria]
1) Patients with excitation/stupor as a primary clinical feature at initiation of the study.
2) Patients with deteriorating or intractable schizophrenia.
3) Patients for whom evaluation of adverse drug reactions (ADRs) cannot be performed.
4) Patients with severe hepatic, renal, cardiac, hematological or gastrointestinal diseases or who have other serious complications.
5) Patients with hypersensitivity to drugs
6) Patients with a history of alcohol or drug abuse
7) Women of childbearing potential, who are pregnant, possibly pregnant or lactating. Women who may wish to become pregnant during the study.
8) Patient with a history or significant likelihood of self-inflicted injury or suicide attempt
9) Others, contraindications or care in administration of risperidone
-Patients in trance.
-Patients strongly affected central nervous system depressants such as barbiturates.
-Patients being treated with epinephrine.
10) Patients otherwise considered by the investigator or the subinvestigator to be ineligible for the study.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified