Summary:
This is an Open-Label Study in Stable Schizophrenia Patients to Evaluate the Safety, Tolerability, and Pharmacokinetics of Switching from Oral Risperidone to Risperidone Implant (DLP-114).
Criteria:- Adult patients 18-55 years of age of both sexes diagnosed with schizophrenia or schizoaffective disorder according to DSM-V who have been stable on oral risperidone (2mg-3mg) for at least 12 weeks.
- Patient (and/or a patient's authorized legal representative) has provided written informed consent
Patient meets the following criteria:
- Outpatient status
- PANSS Total Score ≤ 80 at screening.
- A score of ≤ 4 on the following PANSS items:
i. Conceptual disorganization ii. Suspiciousness iii. Hallucinatory behavior iv. Unusual thought content v. Hostility d. CGI-I-S ≤ 4 (moderately ill)\Lack of clinically significant suicidal ideation or behavior; C-SSRS score type of 4-5 require evaluation by mental health professional to ensure patient safety in study
- Body Mass Index (BMI) within the range of 18.5 to 35.0 kg/m2 (inclusive);
- Ability to understand the nature and objectives of the trial, including risks and adverse events, and be able to read, review and sign the informed consent document prior to conduct of any study procedures;
- Willing and able to comply with the requirements of the study protocol; including willingness to visit the clinical facility for all outpatient visits and confinement periods;
- Have suitable venous access for blood sampling.
- Patient is assessed by the Investigator to be symptomatically stable with regard to pre-existing medical conditions as evidenced by medical history, non-clinically significant findings on physical examination, vital signs, clinical laboratory evaluations (hematology, serum chemistries, and urinalysis) or 12-lead electrocardiogram (ECG). Subjects may continue on their current prescribed medication regimens to control pre-existing medical and psychiatric conditions (other than schizophrenia) including the use of prescribed PRN medications.
Qualified Participants May Receive:
Monetary compensation for participating.