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.
Yes
18 Years to 64 Years
A Biomarker-Guided, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Liafensine in Patients With Treatment Resistant Depression
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.
Yes
18 Years to 70 Years
https://www.denovobiopharma.com/en/index_English.html
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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)
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).
Yes
18 Years to 74 Years
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
The ENCALM trial is designed to evaluate the efficacy and safety of ENX-102 in patients diagnosed with generalized anxiety disorder (GAD)
Yes
Age:
18 to 65 years
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
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.
Yes
Age:
18 to 65 years
Sponsor: Convoke Click CT-155-R-001 Device study
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.
__________________________
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
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.
Yes
Age:
18 Years and older
__________________________
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
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).
Yes
Age:
18 Years to 50 Years
_________________________
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
This is a randomized, Double Blind (DB), placebo-controlled, multicenter study to assess the efficacy and safety of RP5063 (brilaroxazine)
Yes
Age:
18 Years to 65 Years
___________________________
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
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.
Depends on the research institution, ask your coordinator
18 and older
https://www.clicktherapeutics.com/
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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)
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:
Yes
Age:
18 Years to 55 Years
Protocol Number: BHV4157-302
A Randomized, Double-Blind, Placebo-Controlled Trial of Adjunctive Troriluzole in Obsessive Compulsive Disorder
Inclusion criteria:
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:
Sponsor: Abbvie 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:
Sponsor: BioXcel Therapeutics Inc
Protocol Number: BXCL501-401
To Evaluate the Efficacy And Safety of BXCL501 Evaluated For At-Home Use In A Multisite Double-Blind Placebo-Controlled Trial For Agitation Associated With Schizophrenia And Bipolar Disorder
Summary:
Eligibility Criteria:
Patients who have met Diagnostic criteria for bipolar I or bipolar II disorder, schizophrenia, schizoaffective or schizophreniform disorder.
Patients who manage agitation episodes with as needed (PRN) medication
The patient has an Informant who can read, understand, and provide written informed consent and understand and follow the study procedures
Patient Travel Reimbursed?
Yes
Age:
18 Years to 75 years
Clinicaltrials.gov Link:
https://clinicaltrials.gov/study/NCT05658510?term=BioXcel&rank=1
Sponsor Website:
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