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Long-Acting Oral Capsule
Long-Acting Oral LYN-005 for Schizophrenia
Phase 3
Waitlist Available
Led By Richard Scranton, MD, MPH
Research Sponsored by Lyndra Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female aged ≥18 and ≤64 years
Current diagnosis of schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria as confirmed by the Mini International Neuropsychiatric Interview for Psychotic Disorder Studies (MINI) version 7.0.2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 36
Awards & highlights
Study Summary
This trial is studying a long-acting pill form of a drug to treat mental health issues. It will assess the safety, efficacy, and how the body absorbs it.
Who is the study for?
Adults aged 18-64 with a stable diagnosis of schizophrenia or schizoaffective disorder for at least 2 years, currently on oral antipsychotic medication, and in good physical health can join. They must not have gastrointestinal issues, major heart problems within the last 6 months, recent medical procedures, or be using certain medications that affect stomach acid or risperidone absorption.Check my eligibility
What is being tested?
The trial is testing LYN-005, a long-acting oral capsule form of risperidone designed to release medication over time. Participants will receive multiple doses at two different strengths to assess how the body processes it and its safety.See study design
What are the potential side effects?
Potential side effects may include those commonly associated with risperidone such as weight gain, fatigue, restlessness, constipation or diarrhea. Since this is an extended-release formulation there might also be unique side effects related to the long-term presence of the drug in the system.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 64 years old.
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I have been diagnosed with schizophrenia or schizoaffective disorder.
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I have been on a stable dose of my non-antipsychotic medications for at least a month.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to day 36
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 36
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Average Concentration Over the Dosing Interval (Cavg) at Week 5
Maximal Observed Concentration (Cmax) at Week 5
Minimum Observed Concentration (Cmin) at Week 1
+1 moreSecondary outcome measures
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) to Week 5
Number of Participants with Treatment Emergent Adverse Events (TEAEs) From Week 1 to Week 5
Trial Design
2Treatment groups
Experimental Treatment
Group I: LYN-005 Containing 45-mg RisperidoneExperimental Treatment2 Interventions
During the run-in period (Day -7 to Day -1), participants receive Risperdal® (IR risperidone) daily. During the treatment period participants receive 5 weekly doses of LYN-005 45 mg (Days 1, 8, 15, 22, and 29) and Risperdal 3 mg from Day 1 to Day 7.
Group II: LYN-005 Containing 15-mg RisperidoneExperimental Treatment2 Interventions
During the run-in period (Day -7 to Day -1), participants receive Risperdal® (IR risperidone) daily. During the treatment period, participants receive 5 weekly doses of LYN-005 15 mg (Days 1, 8, 15, 22, and 29) and Risperdal 1 mg from Day 1 to Day 7.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LYN-005
2023
Completed Phase 3
~120
Risperidone
2011
Completed Phase 4
~3550
Find a Location
Who is running the clinical trial?
Lyndra Inc.Lead Sponsor
5 Previous Clinical Trials
85 Total Patients Enrolled
1 Trials studying Schizophrenia
34 Patients Enrolled for Schizophrenia
Richard Scranton, MD, MPHPrincipal InvestigatorLyndra Therapeutics INC
2 Previous Clinical Trials
34 Total Patients Enrolled
1 Trials studying Schizophrenia
34 Patients Enrolled for Schizophrenia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had severe period pain or heavy bleeding that needed painkillers in the last 3 months.I have a condition that affects my stomach acid levels.I have had varices or blockages in my intestines before.I have had swallowing problems or choking incidents in the past 5 years.I have had several episodes of stomach pain in the last 3 months.I have moderate to severe acid reflux.I have a serious health condition that is not under control.I have not donated more than 250 mL of blood in the last 30 days.I have had neuroleptic malignant syndrome in the past.I am taking medication to help with stomach emptying.I have not had electroconvulsive therapy in the last 3 months.I haven't used any experimental drugs recently.My genetic test shows I process some medications slowly.I haven't been hospitalized for my schizophrenia worsening in the last 6 months.I have a significant esophageal or gastrointestinal condition.I have a history of esophageal or gastric motility issues.I have been diagnosed with a mental health disorder like depression or anxiety.I have been medically and mentally stable for the last 1 and 3 months, respectively.I am currently taking medication for stomach acid.I have or had significant involuntary movements.I have had a major heart event or was hospitalized for heart failure in the last 6 months.I have experienced significant drops in blood pressure upon standing.I have moderate to severe kidney problems.I have had surgery in my abdomen or upper digestive system.I am not taking medications that affect how risperidone works in my body.I have used depot antipsychotics within the last 9 months.I have had serious issues with diarrhea or constipation in the last 3 months.I have a weakened immune system.I haven't had any major illnesses or surgeries in the last 4 weeks.I have a history of seizures that are not caused by fever.I am taking more than one antidepressant or my dose changed recently.I have been taking the same oral antipsychotic medication for at least 6 weeks.I am between 18 and 64 years old.I have been diagnosed with schizophrenia or schizoaffective disorder.I have been diagnosed with schizophrenia or schizoaffective disorder for 2 years or more.I have been on a stable dose of my non-antipsychotic medications for at least a month.
Research Study Groups:
This trial has the following groups:- Group 1: LYN-005 Containing 15-mg Risperidone
- Group 2: LYN-005 Containing 45-mg Risperidone
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this experiment accommodate participants older than eighteen years?
"This trial has a lower age limit of 18 and an upper age boundary at 64, in accordance with the study's conditions for eligibility."
Answered by AI
What are the prerequisites to becoming a participant in this research endeavor?
"To be eligible to participate in this trial, applicants must have schizophrenia and fall within the stipulated age range (18-64). Approximately 90 recruits are desired."
Answered by AI
Do you still have slots available for participants in this experiment?
"Clinicaltrials.gov reveals that this medical investigation is still recruiting subjects; the trial was initially posted on April 1st 2023 and updated for the last time on April 13th 23rd."
Answered by AI
Has the FDA approved a formulation of risperidone with 45-mg LYN-005?
"There is already existing clinical data that suggests the safety of LYN-005 Containing 45-mg Risperidone, so it received a rating of 3."
Answered by AI
Could you provide a figure for the number of participants involved in this clinical experiment?
"To complete the trial, 90 participants who meet our inclusion criteria must be recruited. These volunteers can sign up at either Atlanta Center for Medical Research in Georgia or Uptown Research Institute in Illinois."
Answered by AI
How many healthcare facilities are currently conducting this research initiative in the urban area?
"Patients are being recruited to this study at the Atlanta Center for Medical Research in Georgia, Uptown Research Institute in Illinois, and Hassman Research Institute in New jersey. An additional 5 medical centres across America are also involved."
Answered by AI
Who else is applying?
What site did they apply to?
CenExel CNS
What portion of applicants met pre-screening criteria?
Met criteria
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