Want to Participate in a Clinical Research Trial for Schizophrenia Agitation?
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Agitation Clinical Research Studies Available to Clinical Trial Participants
Schizophrenia is a chronic, severe mental health disorder that affects how a person thinks, feels, and behaves. People with schizophrenia often experience a combination of symptoms such as delusions (false beliefs), hallucinations (seeing or hearing things that are not there), disorganized thinking, and impaired functioning. Agitation can occur as a part of the illness, either as a direct symptom or as a response to stress, frustration, or confusion.
Schizophrenia with Agitation:
When agitation occurs in someone with schizophrenia, it typically refers to a heightened state of restlessness, irritability, or physical arousal. This agitation can manifest in several ways, including:
- Restlessness: The person may appear constantly fidgety, unable to sit still or relax. They might pace, wring their hands, or make other repetitive movements.
- Irritability: The individual may become easily frustrated or angry, even over small matters. This can sometimes escalate into verbal outbursts or even aggressive behavior.
- Increased Motor Activity: Agitation might lead to more noticeable physical symptoms, such as rapid speech, excessive talking, or impulsive actions. In some cases, people may show signs of aggression or may act impulsively, which can put them at risk of self-harm or harm to others.
- Disorganized Thinking and Speech: Agitation in schizophrenia is often accompanied by disorganized thoughts. This could cause a person to speak incoherently, jump from one topic to another, or struggle to express their thoughts clearly, which may contribute to feelings of frustration.
- Delusions and Hallucinations: Agitation may be linked to delusions or hallucinations, particularly if the person feels threatened or paranoid. If someone with schizophrenia believes they are in danger or are being persecuted (delusions), this can lead to an agitated or combative state.
- Emotional Distress: The person may feel overwhelmed or unable to cope with their thoughts and feelings, which can lead to intense emotional reactions such as crying, shouting, or withdrawal.
If you or someone you love suffers from Schizophrenia and are interested in participating in a clinical trial, please contact us today. Compensation may be available for eligible participants.
Research volunteers play a role in the development of new treatments for some of our most common and debilitating diseases and conditions.
Patients who participate in Excell Research’s clinical trials have an opportunity to join the vanguard of scientific research and contribute to the progress, knowledge, and future treatment of medical conditions.
We will provide you with comprehensive information and straightforward answers to your questions regarding the risks and benefits of participating.
Financial Compensation maybe available to those who qualify
Other Clinical Research Studies Available to Clinical Trial Participants
Depression Clinical Research Studies
Sponsor: ALTO Neuroscience
Protocol Number: ALTO-100-201
Summary:
The purpose of this study is to determine efficacy differences between ALTO-100 and placebo, used either as monotherapy or adjunctively to an antidepressant, related to patient characteristics.
Eligibility Criteria:
Key Inclusion Criteria:
- Have a diagnosis of moderate to severe major depressive disorder (MDD)
- At baseline, either not taking an antidepressant medication, or currently taking a single SSRI, SNRI, mirtazapine, or bupropion for at least 6 weeks with no dose modifications in the past 2 weeks
- Willing to comply with all study assessments and procedures
- Must not be pregnant or breastfeeding at time of enrollment or throughout study
Key Exclusion Criteria:
- Evidence of unstable medical condition
- Diagnosed bipolar disorder, psychotic disorder, or dementia
- Current moderate or severe substance use disorder
- Has a history of hypersensitivity or allergic reaction to ALTO-100 or any of its components/excipients
- Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device
Patient Travel Reimbursed?
Yes
Age:
18 Years to 64 Years
Clinicaltrials.gov Link:
Sponsor Website:
___________________________
Sponsor: DeNovo Biopharma:
Protocol Number: DB104-01
A Biomarker-Guided, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Liafensine in Patients With Treatment Resistant Depression
Summary:
This study will be conducted as a randomized, double-blind, placebo-controlled, multi-center Phase 2b study. Approximately 180 subjects with treatment resistant depression who meet all eligibility criteria will be enrolled.
Eligibility Criteria:
- Have a diagnosis of MDD without psychotic features.
- Have a history of TRD within the past 5 years.
- To be eligible, patients must have DGM4 genotype. (Free testing provided)
Patient Travel Reimbursed?
Yes
Age:
18 Years to 70 Years
Clinicaltrials.gov Link:
Sponsor Website:
https://www.denovobiopharma.com/en/index_English.html
___________________________
Sponsor: Janssen Research and Development:
Protocol Number: 67953964MDD3001
A Randomized, Double-blind, Placebo controlled study to evaluate the Safety and Efficacy of Aticaprant as Adjunctive Therapy in Adult and Elderly Participants With Major Depressive Disorder (MDD)
Summary:
The purpose of this study is to assess the long-term safety and tolerability of Aticaprant administered as adjunctive therapy to a current antidepressant (selective serotonin reuptake inhibitor [SSRI] or serotonin and norepinephrine reuptake inhibitor [SNRI]) in all participants with major depressive disorder (MDD).
Eligibility Criteria:
- Have had an inadequate response to at least 1 oral antidepressant treatment.
- Meet diagnostic criteria for recurrent or single episode major depressive disorder (MDD), without psychotic features.
Patient Travel Reimbursed?
Yes
Age:
18 Years to 74 Years
Clinicaltrials.gov Link:
Sponsor Website:
Generalized Anxiety Clinical Research Studies
Sponsor: Engrail Therapeutics
Protocol Number: ENX-102-003
The ENCALM Trial: A Randomized, Double-blind, Placebo-controlled Monotherapy Trial to Evaluate the Efficacy and Safety of ENX-102 in Patients With Generalized Anxiety Disorder
Summary:
The ENCALM trial is designed to evaluate the efficacy and safety of ENX-102 in patients diagnosed with generalized anxiety disorder (GAD)
Eligibility Criteria:
- Moderate-Severe symptoms of Generalized Anxiety over the past 6 months.
- GAD must be the primary source of treatment. Primary Depression or PTSD are considered exclusionary.
- History of BPAD and Schizophrenia are considered exclusionary.
Patient Travel Reimbursed?
Yes
Age:
18 to 65 years
Clinicaltrials.gov Link:
Sponsor Website:
___________________________
Sponsor: Sunovion
Protocol Number: SEP361-226
A Phase 2/3, Randomized, Double-blind, Parallel Group, Placebo-controlled, Flexible-dose, Multicenter Study to Evaluate the Efficacy and Safety of SEP-363856 in the Treatment of Adults With Generalized Anxiety Disorder
Summary:
A clinical study that will measure how well SEP-363856 works and how safe it is in adults with Generalized Anixety Disorder. This study will be accepting both male and female subjects between the ages of 18 years and 65 years old.
Eligibility Criteria:
- Moderate-Severe symptoms of Generalized Anxiety over the past 6 months.
- GAD must be the primary source of treatment. Primary Depression or PTSD are considered exclusionary.
- History of BPAD and Schizophrenia are considered exclusionary.
Patient Travel Reimbursed?
Yes
Age:
18 to 65 years
Clinicaltrials.gov Link:
Sponsor Website:
Schizophrenia Clinical Research Studies
Sponsor: Convoke Click CT-155-R-001 Device study
Summary:
The Convoke Study will look at 2 mobile applications (apps) to see if they can
support people with moderate to severe negative schizophrenia symptoms.
These apps are investigational prescription digital therapeutics (PDTs) that are
downloaded onto your smartphone. This study will see if an app can be part of
a schizophrenia treatment plan. The results of this study could help other people
who experience negative symptoms of schizophrenia.
Eligibility Criteria:
• are at least 18 years of age
• have a primary diagnosis of schizophrenia
• have been on a stable dose of antipsychotic medication for at least 12 weeks
before the study treatment period
• own a smartphone compatible with Android 10 or greater, or iOS 14 or greater
To participate in the study, you must be available to use a mobile app for up to
22 weeks. The study also includes 4 study center assessment visits and 3 phone calls.
An Institutional Review Board (IRB) has approved this study. This does not mean
your participation in the study is approved. An IRB protects the rights, safety, and
well-being of the participants.
Clinicaltrials.gov Link:
Sponsor Website:
__________________________
Sponsor: Neurocrine Biosciences
Protocol Number: NBI-98854-ATS3019
A Phase 3, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment in Subjects With Schizophrenia
Summary:
The primary objective for this study is to evaluate the effect of adjunctive valbenazine versus placebo on symptoms of schizophrenia in participants who have inadequate response to antipsychotic treatment. Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of valbenazine when administered orally once daily as adjunctive treatment in participants with schizophrenia who have had an inadequate response to antipsychotics.
Eligibility Criteria:
- Medically confirmed diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
- The initial diagnosis of schizophrenia must be ≥1 year prior to screening.
- The participant is treated with a stable regimen antipsychotic medication.
Patient Travel Reimbursed?
Yes
Age:
18 Years and older
Clinicaltrials.gov Link:
Sponsor Website:
__________________________
Sponsor: Neurocrine Biosciences
Protocol Number: NBI-1065844-CIAS2023
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Luvadaxistat in Subjects With Cognitive Impairment Associated With Schizophrenia, Followed by Open-Label Treatment
Summary:
A Phase 2, randomized, double-blind, parallel, placebo-controlled study with a 12-month open-label extension. The study is designed to evaluate the efficacy, safety and tolerability, and pharmacokinetics (PK) of treatment with luvadaxistat when administered orally once daily as an adjunctive treatment on improving symptoms of cognitive impairment associated with schizophrenia (CIAS).
Eligibility Criteria:
Key Inclusion Criteria:
- Diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
- The initial diagnosis of schizophrenia must be ≥1 year before screening.
- The participant is currently receiving a stable regimen of psychotropic medications.
- Participant has stable symptomatology ≥3 months before the screening visit.
- A body weight of at least 45 kilograms (kg) and a body mass index (BMI) of 18.0 to 45.0 kg/meter squared (m^2), inclusive.
Patient Travel Reimbursed?
Yes
Age:
18 Years to 50 Years
Clinicaltrials.gov Link:
Sponsor Website:
_________________________
Sponsor: Reviva Pharmaceuticals
Protocol Number: RVP-30-001
Phase 3, Randomized, 28 Days, Double-blind, Placebo-controlled, Multicenter Study to Assess the Safety and Efficacy of Brilaroxazine (RP5063) in Subjects With Schizophrenia, Followed by a 52-Week Open-label Extension
Summary:
This is a randomized, Double Blind (DB), placebo-controlled, multicenter study to assess the efficacy and safety of RP5063 (brilaroxazine)
Eligibility Criteria:
- Subject is male or female, aged 18 to 65 years
- Diagnosis of schizophrenia between 1-20 years.
- Be willing to discontinue current medications after screening.
Patient Travel Reimbursed?
Yes
Age:
18 Years to 65 Years
Clinicaltrials.gov Link:
Sponsor Website:
___________________________
Sponsor: Click Therapeutics
Protocol Number: CT-155-R-001
A Randomized, Multicenter, 16-week Study to Evaluate the Efficacy and Safety of Two Prescription Digital Therapeutics as an Adjunct to Standard-of-Care Antipsychotic Therapy in Adult and Late Adolescent Participants With Experiential Negative Symptoms of
Summary:
The purpose of the proposed study is to evaluate the efficacy and safety of two prescription digital therapeutics as an adjunct treatment to SOC in participants 18 years of age or older diagnosed with experiential negative symptoms of schizophrenia.
Eligibility Criteria:
- Has a primary diagnosis of schizophrenia.
- Is on a stable dose of antipsychotic medication(s).
- Has obtained an average score of ≥2 (moderate to severe) in at least two of the three CAINS-MAP domains (Social, Work, or Recreational).
- Have a device with updated IOS or Android OS systems.
Patient Travel Reimbursed?
Depends on the research institution, ask your coordinator
Age:
18 and older
Clinicaltrials.gov Link:
Sponsor Website:
https://www.clicktherapeutics.com/
_________________________
Sponsor: Recognify Life Sciences
Protocol Number: C07-03-02
An Adaptive, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of RL-007 in the Treatment of Cognitive Impairment Associated With Schizophrenia (CIAS)
Summary:
The goal of this clinical trial is to evaluate if the investigational drug, RL-007, can improve the cognitive performance of subjects with schizophrenia.
Eligibility Criteria:
- Diagnosis of schizophrenia, per Diagnostic and Statistical Manual (DSM) 5, with a duration of at least 6 months
- Positive and Negative Symptoms Severity Score (PANSS) of less than or equal to 80 (inclusive)
- Currently treated on a single atypical antipsychotic (other than clozapine) at a stable dose and clinically stable for at least 6 weeks before randomization
- Clinical Global Impression – Severity score < 5
Patient Travel Reimbursed?
Yes
Age:
18 Years to 55 Years
Clinicaltrials.gov Link:
Sponsor Website:
OCD Clinical Research Studies
- Sponsor: Biohaven Pharmaceuticals
Protocol Number: BHV4157-302
A Randomized, Double-Blind, Placebo-Controlled Trial of Adjunctive Troriluzole in Obsessive Compulsive Disorder
Inclusion criteria:
-
- Age 18-65
- Moderate to severe symptoms of OCD.
- Currently taking an SSRI medication for 8 weeks prior to the study.
- Reimbursement for time and travel up to $700.
Adolescent Migraine Clinical Research Studies
- Sponsor: Abbvie Pharmaceuticals
Protocol Number: 3110-305-002 & M21-201
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Single-attack Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral Ubrogepant in the Acute Treatment of Migraine With or Without Aura in Children and Adolescents (Ages 6-17)
Inclusion criteria:
-
- Age 11-17 (Excell Research Age Range)
- Have up to 4 Migraines days a month.
- No previous medications required.
- Reimbursement for time and travel up to $300.
Sponsor: Abbvie Pharmaceuticals
Alzheimer's Disease Clinical Research Studies
- Sponsor: Otsuka Pharmaceuticals
Protocol Number: 20-AVP-786-306
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer’s Type
Inclusion criteria:
-
- Age 50-90
- Previous diagnosis of Alzheimer’s Disease and a legal caregiver required.
- Reimbursement for time and travel up to $1,000 for patient and caregiver.
Research volunteers play a role in the development of new treatments for some of our most common and debilitating diseases and conditions.
Patients who participate in Excell Research’s clinical trials have an opportunity to join the vanguard of scientific research and contribute to the progress, knowledge, and future treatment of medical conditions.
We will provide you with comprehensive information and straightforward answers to your questions regarding the risks and benefits of participating.
Financial Compensation maybe available to those who qualify and complete visits for our Clinical Trials.
Pre-Screening Questionnaire and Your Privacy
Please be advised that by filling out the study pre-screening questionnaire, you will be asked to provide personal information, including age, gender, and your current medical condition. One of our staff will then reach out to conduct a phone-screen to see if you qualify for one of our current studies at our office location in Oceanside, CA. Your privacy is of the utmost importance to Excell Research. Your privacy will be protected and the information you provide will only be shared with those involved with the clinical research study if it is determined that you may be eligible to participate, unless you permit us to do so or except as required by law. Your information will not be sold to outside companies, nor will it be stored or collected without your direct consent.
Many Pharmaceutical Companies and Excell Research are conducting these studies under the Food and Drug Administration (FDA) to learn more about new investigational drugs or treatments. Read our privacy policy to learn more about how your information will be kept private.
Resources for Agitation
Agitation
Agitation is a feeling of irritability or severe restlessness. It is common in people with a history of psychiatric conditions and has different treatment plans varying based off the patient and provider. Significant agitation can also occur in people who suffer from Dementia or Alzheimer’s Disease. Symptoms of agitation can include restlessness associated with mental distress, excessive motor activity or forms of aggression. Aggression can come in multiple forms including verbal and physical towards themselves or other people. Many people who experience significant agitation experience behavioral disturbances, diagnostic cues, and management protocols in different settings.
Agitation can commonly be found in people with a history of
- Psychosis
- Bipolar Disorder Type I/Type II
- Schizophrenia
- Schizoaffective Disorder
- Schizophreniform Disorder and more
There are current treatments in place to assist someone experiencing an agitation episode. Noncoercive de-escalation skills are important for dealing with someone experiencing an agitation episode. Medications can also be used to treat someone having an agitation episode. Common medications used to treat agitation include different benzodiazepines like Lorazepam or antipsychotic medications. Generally, these medications are used as a last resort to treat an agitation episode.
