Molindone

Generic Name: Molindone

Drug Type: Small Molecule

Chemical Formula: C_₁₆H_₂₄N_₂O_₂

CAS Number: 7416-34-4

Unique Ingredient Identifier: RT3Y3QMF8N

Background: An indole derivative effective in schizophrenia and other psychoses and possibly useful in the treatment of the aggressive type of undersocialized conduct disorder. Molindone has much lower affinity for D2 receptors than most antipsychotic agents and has a relatively low affinity for D1 receptors. It has only low to moderate affinity for cholinergic and alpha-adrenergic receptors. Some electrophysiologic data from animals indicate that molindone has certain characteristics that resemble those of clozapine. (From AMA Drug Evaluations Annual, 1994, p283)

Indication: Molindone is used for the management of the manifestations of psychotic disorders.

Associated Conditions: Schizophrenia

Clinical Trials

Exploratory fMRI Study on the Treatment for Impulsive Aggression in Children With ADHD

Phase 2

Terminated

Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Impulsive Aggression

Interventions: Diagnostic Test: Functional Magnetic Resonance Imaging (fMRI)
Diagnostic Test: Magnetic Resonance Spectroscopy (MRS)
Behavioral: Point Subtraction Aggression Paradigm (PSAP) Task
Drug: SPN-810
Drug: Placebo

First Posted Date: 2018-08-20

Last Posted Date: 2025-05-02

Lead Sponsor: Supernus Pharmaceuticals, Inc.

Target Recruit Count: 7

Registration Number: NCT03638466

Locations: 🇺🇸
Florida Clinical Research Center, LLC., Maitland, Florida, United States
🇺🇸
University of South Florida- Dept. of Psychiatry and Neurosciences, Tampa, Florida, United States
🇺🇸
Meridien Research aka Florida Clinical Research Center, LLC, Lakeland, Florida, United States

Treatment of Impulsive Aggression (IA) in Adolescent With ADHD in Conjunction With Standard ADHD Treatment

Phase 3

Terminated

Conditions: Attention Deficit Hyperactivity Disorder

Interventions: Drug: SPN-810
Drug: Placebo

First Posted Date: 2018-07-24

Last Posted Date: 2024-04-24

Lead Sponsor: Supernus Pharmaceuticals, Inc.

Target Recruit Count: 41

Registration Number: NCT03597503

Locations: 🇺🇸
iResearch Atlanta, Decatur, Georgia, United States
🇺🇸
Hassmann Research Institute, Berlin, New Jersey, United States
🇺🇸
Family Psychiatry of the Woodlands, The Woodlands, Texas, United States

and more 35 locations

Treatment of Impulsive Aggression in Subjects With ADHD in Conjunction With Standard ADHD Treatment (CHIME 4)

Phase 3

Terminated

Conditions: Attention Deficit Hyperactivity Disorder (ADHD)

Interventions: Drug: SPN-810

First Posted Date: 2016-02-25

Last Posted Date: 2024-05-16

Lead Sponsor: Supernus Pharmaceuticals, Inc.

Target Recruit Count: 491

Registration Number: NCT02691182

Locations: 🇺🇸
CNS Healthcare of Orlando, Orlando, Florida, United States

Phase I Study to Assess the Absorption, Metabolism, and Excretion of [14C] Labeled SPN-810M

Phase 1

Completed

Conditions: Impulsive Aggression Comorbid With ADHD

Interventions: Drug: SPN-810M

First Posted Date: 2013-12-30

Last Posted Date: 2016-05-13

Lead Sponsor: Supernus Pharmaceuticals, Inc.

Target Recruit Count: 7

Registration Number: NCT02023606

Locations: 🇬🇧
Quotient Clinical, Ruddington, Nottingham, United Kingdom

Open-Label, Extension Study to 810P202

Phase 2

Completed

Conditions: Impulsive Aggression Comorbid With ADHD in Children

Interventions: Drug: Molindone

First Posted Date: 2011-08-12

Last Posted Date: 2017-05-02

Lead Sponsor: Supernus Pharmaceuticals, Inc.

Target Recruit Count: 78

Registration Number: NCT01416064

A Study to Evaluate the Efficacy and Safety of SPN-810 as Adjunctive Therapy in Children With Impulsive Aggression Comorbid With Attention-Deficit/Hyperactivity Disorder (ADHD)

Phase 2

Completed

Conditions: Impulsive Aggression Comorbid With ADHD

Interventions: Drug: Placebo
Drug: SPN-810

First Posted Date: 2011-06-02

Last Posted Date: 2021-02-11

Lead Sponsor: Supernus Pharmaceuticals, Inc.

Target Recruit Count: 121

Registration Number: NCT01364662

Phase 2a Study of Safety and Tolerability of SPN-810 in Children With ADHD and Persistent Serious Conduct Problems

Phase 2

Completed

Conditions: Attention Deficit Disorder With Hyperactivity
Conduct Disorder

Interventions: Drug: SPN-810

First Posted Date: 2008-02-29

Last Posted Date: 2013-01-28

Lead Sponsor: Supernus Pharmaceuticals, Inc.

Target Recruit Count: 78

Registration Number: NCT00626236

Locations: 🇺🇸
Florida Clinical Research Center, Bradenton, Florida, United States
🇺🇸
Sarkis Clinical Trials, Gainesville, Florida, United States
🇺🇸
CNS Healthcare, Orlando, Florida, United States

and more 6 locations

Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS)

Phase 4

Completed

Conditions: Schizophrenia

Interventions: Drug: Olanzapine (enrollment closed in this treatment)
Drug: Risperidone
Drug: Molindone

First Posted Date: 2003-02-05

Last Posted Date: 2014-03-26

Lead Sponsor: University of North Carolina, Chapel Hill

Target Recruit Count: 116

Registration Number: NCT00053703

Locations: 🇺🇸
University of Washington, Seattle, Washington, United States
🇺🇸
University of North Carolina, Chapel Hill, North Carolina, United States
🇺🇸
Cambridge Health Alliance, Medford, Massachusetts, United States

and more 1 locations

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