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Serotonin Receptor Agonist
Lorcaserin for Weight Loss in Patients on Antipsychotics
Phase 4
Waitlist Available
Research Sponsored by Southern California Institute for Research and Education
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The patient's BMI is greater than or equal to 30 kg/m2 OR the patient's BMI is greater than or equal to 27 kg/m2 in the presence of at least one weight-related co-morbidity such as hypertension, type 2 diabetes mellitus, dyslipidemia, metabolic syndrome, obstructive sleep apnea, or degenerative joint disease such as osteoarthritis.
Patients currently on atypical antipsychotics
Timeline
Screening 3 weeks
Treatment Varies
Follow Up initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
Awards & highlights
Study Summary
This trial will test whether the drug lorcaserin can help people with weight gain from antipsychotic medications lose weight.
Who is the study for?
This trial is for adults aged 18-65 who gained weight from antipsychotic meds, with a BMI ≥30 or ≥27 with conditions like hypertension. They must commit to follow-up visits and not be on other weight loss drugs, have severe heart valve issues, recent drug abuse, suicidal thoughts, dementia, or be pregnant/breastfeeding.Check my eligibility
What is being tested?
The study tests if lorcaserin helps patients on antipsychotics lose weight. It includes intensive dietary counseling and regular check-ins over 16 weeks to monitor progress and effectiveness of the medication in reducing body weight.See study design
What are the potential side effects?
Lorcaserin may cause headaches, dizziness, fatigue, nausea, dry mouth or constipation. Serious side effects could include heart-related issues due to its action on serotonin receptors but are less common.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My BMI is 30 or higher, or it's 27 or higher with a weight-related health issue.
Select...
I am currently taking medication for mental health that is not a typical antipsychotic.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Weight loss
Secondary outcome measures
Evaluation of blood count
Evaluation of body-mass index (BMI)
Evaluation of cholesterol control
+9 moreSide effects data
From 2018 Phase 2 trial • 97 Patients • NCT0290664436%
Vivid Dreams
23%
Itching at Patch Site
21%
Fatigue
13%
Dry Mouth
9%
Constipation
9%
Coughing
9%
Rash at Patch Site
7%
Insomnia
5%
Nausea
5%
Dizziness/Lightheadedness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lorcaserin + Patch
Patch (1st 2 Weeks)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Lorcaserin with intensive diet counselingExperimental Treatment2 Interventions
Patients will be taking lorcaserin 10mg tablet by mouth twice daily. In addition, patients will be provided with intensive dietary counseling to promote weight loss.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lorcaserin
FDA approved
Find a Location
Who is running the clinical trial?
Southern California Institute for Research and EducationLead Sponsor
26 Previous Clinical Trials
1,769 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a known allergy or sensitivity to lorcaserin.I can give my own consent or have a conservator to do so for me.My BMI is 30 or higher, or it's 27 or higher with a weight-related health issue.I am currently taking medication for mental health that is not a typical antipsychotic.You have not had thoughts of hurting yourself in the past 3 months.You have a condition called dementia.I have moderate to severe leakage in my heart valves.I am either younger than 18 or older than 65.I am currently taking medication for weight loss.I agree to attend all scheduled follow-up appointments after starting the medication.
Research Study Groups:
This trial has the following groups:- Group 1: Lorcaserin with intensive diet counseling
Awards:
This trial has 4 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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.
Have there been any investigations with regards to lorcaserin's efficacy?
"Presently, 3 clinical trials related to lorcaserin are underway. One of those investigations is in Phase 3 and based primarily in Boston, Massachusetts; however, 43 other locations are running corresponding studies for this medication."
Answered by AI
Is this research initiative available to persons older than 45 years of age?
"To be eligible for this experiment, individuals must meet the age requirement of 18 to 65 years old. 61 studies exist specifically for minors and 226 studies are tailored towards patients above the senior threshold."
Answered by AI
Has lorcaserin been proven to pose minimal risk for human users?
"Several clinical trials have validated the safety of lorcaserin, thus it has been rated a 3 on our scale. This substance is already approved for general use in many countries."
Answered by AI
Do I meet the qualifications to participate in this medical trial?
"To qualify for this research, participants should be of age between 18-65 and have experienced weight gain. This study requires the enrollment of 15 individuals."
Answered by AI
Are investigators currently enrolling participants in this research endeavor?
"This clinical trial has closed down, as the last update was made on January 29th 2014. If you are in search of other trials, there are currently 340 studies that involve weight gain and 3 studies for lorcaserin actively recruiting patients."
Answered by AI
How many participants are receiving treatment through this clinical experiment?
"This trial is not presently enrolling; according to the data on clinicaltrials.gov, it was first posted on January 1st 2014 and last updated nearly a month later. If other studies are sought, there are currently 340 trials investigating weight gain and 3 involving lorcaserin that need participants."
Answered by AI
Who else is applying?
What state do they live in?
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
VA Long Beach
Why did patients apply to this trial?
Really to lose weight and help future overweight women like me. Because I need to get my weight under control after taking mental health medication.
PatientReceived 2+ prior treatments
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