Decatur, Georgia
Safety, Tolerability, and Pharmacokinetics of KarXT and Dual-burst Release of Xanomeline With Immediate-release Trospium Chloride in Adolescents With Psychiatric Disorders
Phase
1Span
36 weeksSponsor
Bristol-Myers SquibbDecatur, Georgia
Recruiting
A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder
Phase
3Span
98 weeksSponsor
Xenon Pharmaceuticals Inc.Decatur, Georgia
Recruiting
A Study to Evaluate the Efficacy and Safety of Once-Weekly MET097 in Adults With Obesity or Overweight and T2DM
This is a 28-week, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy, safety, and tolerability of four different once-weekly MET097 dosing regimens vs. placebo for body weight loss in adults (18-75 years of age) with obesity or overweight (body mass index [BMI] ≥27 to ≤50 kg/m2) and T2DM . After completing 28 weeks of study treatment, all participants will be followed for approximately 4 weeks after administration of the last dose of study treatment.
Phase
2Span
68 weeksSponsor
MetseraDecatur, Georgia
Recruiting
A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia
Phase
3Span
184 weeksSponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.Decatur, Georgia
Recruiting
A Phase 2 Randomized Double-Blind, Parallel, Adaptive-Design, Clinical Trial to Evaluate the Safety and Efficacy of NRCT-101SR with NRCT-202XR Compared to NRCT-202XR Alone in Subjects with Attention-Deficit/Hyperactivity Disorder
A multi-center, randomized, double-blind, parallel, adaptive-design clinical trial to evaluate the safety and efficacy of co-administration of NRCT-101SR and low dose NRCT- 202XR compared to low or high dose of NRCT-202XR and placebo NRCT-101SR over a 6-week period in approximately 60 pediatric subjects (13-17 years of age) with ADHD. Subjects' enrollment will be conducted in two stages. In stage 1, subjects are planned to be randomized to one of the following two arms (1:1 ratio): Arm 1: NRCT-101SR and low dose NRCT-202XR Arm 2: NRCT-101SR placebo and high dose NRCT-202XR In stage 2, a third study arm will be added (Arm 3 - NRCT-101SR placebo and low dose NRCT-202XR. The study population will include male and female subjects (sex assigned at birth) of all races/ethnicities with ADHD.
Phase
2Span
40 weeksSponsor
Neurocentria, Inc.Decatur, Georgia
Recruiting
Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder
The study will be conducted in 3 periods: - Screening Period (up to 2 weeks) during which patient eligibility will be assessed and the washout of prohibited medications will occur; - Double-blind Treatment Period (6 weeks) during which a total of approximately 570 patients are planned to be randomized in a 1:1:1 ratio to receive one of the 3 treatments (ITI-1284 10 mg, ITI-1284 20 mg, or placebo); - Safety Follow-up Period (1 week) during which all patients will return for a safety follow-up visit approximately 1 week after the last dose of study drug.
Phase
2Span
136 weeksSponsor
Intra-Cellular Therapies, Inc.Decatur, Georgia
Recruiting
Efficacy, Safety & Pharmacokinetic (PK) Study of HLD200 in Children Aged 4-5 Years with ADHD
This is a multicenter, 3 week fixed dose, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy, safety and pharmacokinetics of HLD200 (20 mg and 40 mg) in children aged 4 to 5 years with ADHD. Participants will be screened for eligibility for up to 4 weeks. Eligible participants will be treated with study medication for 3 weeks followed by a 2 week safety follow-up following the end of study treatment. The total duration of the study is up to 9 weeks. A single pharmacokinetic (PK) sample will be taken from each participant, in a prespecified PK sampling window at visit 5, for population PK analysis. A total of 168 participants (56 per treatment arm) will be randomized at Visit 2.
Phase
3Span
98 weeksSponsor
Ironshore Pharmaceuticals and Development, IncDecatur, Georgia
Recruiting
Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective Disorder
Phase
1Span
84 weeksSponsor
Intra-Cellular Therapies, Inc.Decatur, Georgia
Recruiting
Study of ABX-002 for the Adjunctive Treatment of Major Depressive Disorder (AMPLIFY)
Phase
2Span
56 weeksSponsor
Autobahn Therapeutics, Inc.Decatur, Georgia
Recruiting
Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-4)
Phase
3Span
111 weeksSponsor
VistaGen Therapeutics, Inc.Decatur, Georgia
Recruiting