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  • Safety, Tolerability, and Pharmacokinetics of KarXT and Dual-burst Release of Xanomeline With Immediate-release Trospium Chloride in Adolescents With Psychiatric Disorders

    Phase

    1

    Span

    36 weeks

    Sponsor

    Bristol-Myers Squibb

    Decatur, Georgia

    Recruiting

  • A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder

    Phase

    3

    Span

    98 weeks

    Sponsor

    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

    2

    Span

    68 weeks

    Sponsor

    Metsera

    Decatur, Georgia

    Recruiting

  • A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia

    Phase

    3

    Span

    184 weeks

    Sponsor

    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

    2

    Span

    40 weeks

    Sponsor

    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

    2

    Span

    136 weeks

    Sponsor

    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

    3

    Span

    98 weeks

    Sponsor

    Ironshore Pharmaceuticals and Development, Inc

    Decatur, Georgia

    Recruiting

  • Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective Disorder

    Phase

    1

    Span

    84 weeks

    Sponsor

    Intra-Cellular Therapies, Inc.

    Decatur, Georgia

    Recruiting

  • Study of ABX-002 for the Adjunctive Treatment of Major Depressive Disorder (AMPLIFY)

    Phase

    2

    Span

    56 weeks

    Sponsor

    Autobahn Therapeutics, Inc.

    Decatur, Georgia

    Recruiting

  • Fasedienol Nasal Spray for the Acute Treatment of Anxiety in Adults With Social Anxiety Disorder (PALISADE-4)

    Phase

    3

    Span

    111 weeks

    Sponsor

    VistaGen Therapeutics, Inc.

    Decatur, Georgia

    Recruiting

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