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Risperidone for Schizophrenia (DLP-114 Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by Delpor, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-12 months
Awards & highlights

DLP-114 Trial Summary

This trial is testing if it's safe to switch from oral risperidone to risperidone implants in people with stable schizophrenia.

DLP-114 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events
Local Tolerance
Tolerability of Implantation and Explantation Procedures
Secondary outcome measures
Clinical Global Impression-Improvement (CGI-I) Scale
Determine potential implant migration
Implant Pharmacokinetic (PK) Profile
+4 more

DLP-114 Trial Design

2Treatment groups
Experimental Treatment
Group I: DLP-114 alpha-7 (12-months)Experimental Treatment1 Intervention
2 435mg Risperidone Implants
Group II: DLP-114 alpha-4 (6-months)Experimental Treatment1 Intervention
2 360mg Risperidone Implants
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Risperidone
2011
Completed Phase 4
~3550

Find a Location

Who is running the clinical trial?

Delpor, Inc.Lead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,739 Total Patients Enrolled
249 Trials studying Schizophrenia
89,407 Patients Enrolled for Schizophrenia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available to join this research study?

"This trial is no longer open for recruitment. It was first posted on April 1st 2021 and the last update occurred November 27th 2022. If you are looking to participate in another clinical study, there exist 333 trials searching for patients with schizophrenia and 17 studies specifically seeking out enrolment of those using Risperidone as treatment."

Answered by AI

What is the essential aim of this clinical experiment?

"According to the research sponsor, Delpor, Inc., this trial's primary metric will be Local Tolerance over a period of 6-12 months. Additionally, there are three secondary metrics that need to be monitored: Implant device placement depth (measured via ultrasound), Implant Pharmacokinetic Profile (blood plasma concentration of risperidone and 9-OH risperidone following implantation) and Oral Pharmacokinetic Profile (blood plasma measurements taken after oral administration)."

Answered by AI

What conditions has Risperidone been found to ameliorate?

"Most widely used to address acute coryza, risperidone has also been seen as a viable treatment for multiple other ailments such as autistic disorder, bipolar disorder and irritability."

Answered by AI

Does this trial accept minors as participants?

"The requirements for inclusion in this trial state that potential participants must be aged 18 or above and under 70 years old."

Answered by AI

Are there any other investigations with regards to the efficacy of Risperidone?

"Risperidone was initially investigated in 2004 at the Psychiatric Service of Tel-Aviv Sourasky Medical Center. 205 associated clinical trials have been conducted to date, with 17 live studies as of now; many occurring near Miami Lakes, Florida."

Answered by AI

Who meets the criteria to participate in this trial?

"This clinical trial is enrolling 30 people with schizophrenia aged between 18 and 70. Core inclusion criteria include: diagnosis of DSM-V defined schizophrenia or schizoaffective disorder, stable oral risperidone 2mg to 3mg for two weeks prior, written informed consent from the patient/legal representative, outpatient status as evidenced by PANSS Total Score ≤ 80 at screening and CGI-I-S ≤ 4 (moderately ill), C-SSRS score type of 4 - 5 requiring evaluation for safety purposes if present, BMI within 18.5 to 40.0 kg/m2 range, suitable venous access for blood sampling"

Answered by AI

What is the uppermost limit of people engaged in this research?

"This trial is no longer active and applications are not being accepted. The study was originally posted on April 1, 2021 with its last update made on November 27th 2022. For those looking for alternative trials, there are 333 clinical studies involving schizophrenia currently recruiting patients and 17 investigations concerning Risperidone that have open enrollment slots available."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~7 spots leftby Apr 2025