WARNING
Increased Mortality in Elderly Patients with Dementia-Related Psychosis — Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. MOBAN is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS).
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MOBAN SUMMARY
MOBAN®
(Molindone Hydrochloride Tablets, USP)
Rx Only
MOBAN (molindone hydrochloride) is a dihydroindolone compound which is not structurally related to the phenothiazines, the butyrophenones or the thioxanthenes.
MOBAN is indicated for the management of schizophrenia. The efficacy of MOBAN in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized, acutely ill, schizophrenic patients as subjects.
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NEWS HIGHLIGHTSMedia Articles Related to Moban (Molindone)
Schizophrenia Quiz: What is Schizophrenia?
Source: MedicineNet Schizophrenia Specialty [2017.09.19]
Title: Schizophrenia Quiz: What is Schizophrenia?
Category: MedicineNet Quiz
Created: 1/26/2011 12:00:00 AM
Last Editorial Review: 9/19/2017 5:20:02 PM
Magnetic Brain Stimulation May Quiet 'Voices' in Schizophrenia
Source: MedicineNet Schizophrenia Specialty [2017.09.08]
Title: Magnetic Brain Stimulation May Quiet 'Voices' in Schizophrenia
Category: Health News
Created: 9/7/2017 12:00:00 AM
Last Editorial Review: 9/8/2017 12:00:00 AM
'Recovery-Oriented' Talk Therapy May Help Curb Schizophrenia
Source: MedicineNet Schizophrenia Specialty [2017.06.07]
Title: 'Recovery-Oriented' Talk Therapy May Help Curb Schizophrenia
Category: Health News
Created: 6/6/2017 12:00:00 AM
Last Editorial Review: 6/7/2017 12:00:00 AM
Bipolar Disorder vs. Schizophrenia
Source: MedicineNet Schizophrenia Specialty [2017.05.18]
Title: Bipolar Disorder vs. Schizophrenia
Category: Diseases and Conditions
Created: 5/18/2017 12:00:00 AM
Last Editorial Review: 5/18/2017 12:00:00 AM
Schizophrenia
Source: MedicineNet Electroconvulsive Therapy Specialty [2016.10.24]
Title: Schizophrenia
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 10/24/2016 12:00:00 AM
Published Studies Related to Moban (Molindone)
D-cycloserine adjuvant therapy to molindone in the treatment of schizophrenia. [1996.10]
This preliminary investigation examined the therapeutic efficacy of two doses of oral D-cycloserine (5 and 15 mg p.o.Additionally, there might be a therapeutic window for D-cycloserine dosing, as daily doses of 250 mg have been associated with symptom worsening.
A comparison of masking effects of haloperidol versus molindone in tardive dyskinesia. [1990.10]
An experimental method was utilized to compare the masking effects of two neuroleptic agents--molindone and haloperidol--on 18 neuroleptic-treated schizophrenic patients exhibiting operationally defined withdrawal-exacerbated tardive dyskinesia. After a week on one of these two medications at preestablished doses equivalent to that of the pre-study neuroleptic, molindone-masked total AIMS scores by significantly less (12%) than haloperidol (27%).
Molindone for schizophrenia and severe mental illness. [2007.01.24]
CONCLUSIONS: The strength of the evidence relating to this compound is limited, owing to small sample size, poor study design, limited outcomes and incomplete reporting. Molindone may be an effective antipsychotic but its adverse effect profile does not differ significantly from that of typical antipsychotics (apart from the event of weight loss). Data from this review suggest, at present, there is no evidence to suggest that it may have an atypical profile.
Molindone for schizophrenia and severe mental illness. [2000]
CONCLUSIONS: The strength of the evidence relating to this compound is limited, owing to small sample size, poor study design, limited outcomes and incomplete reporting. Molindone may be an effective antipsychotic; however, its adverse effect profile does not differ significantly from that of typical antipsychotics, apart from the event of weight loss. At present there is no evidence to suggest that it may have an atypical profile.
Treatment of clozapine- and molindone-induced agranulocytosis with granulocyte colony-stimulating factor. [1993.10]
CONCLUSIONS: Filgrastim may be useful in ameliorating the effects of clozapine- and molindone-induced agranulocytosis.
Clinical Trials Related to Moban (Molindone)
Treatment of Early Onset Schizophrenia Spectrum Disorders (TEOSS) [Completed]
This study will evaluate the safety and efficacy of risperidone (Risperdal®), olanzapine
(Zyprexa®), and molindone (Moban®) for the treatment of children and adolescents with
schizophrenia or schizoaffective disorder.
Open-Label, Extension Study to 810P202 [Completed]
Open-label, extension study for subjects that completed 810P202 to examine long term safety
and tolerability of repeated dosing of SPN-810M as an adjunctive therapy in children with
Impulsive Aggression Comorbid with Attention-Deficit/Hyperactivity Disorder (ADHD).
A Study to Evaluate the Efficacy and Safety of Molindone Hydrochloride XR Tablets as Adjunctive Therapy in Children With Impulsive Aggression Comorbid With Attention-Deficit/Hyperactivity Disorder (ADHD) [Completed]
This will be a randomized, double-blind, placebo-controlled, dose-ranging, efficacy and
safety study in children with impulsive aggression comorbid with
Attention-Deficit/Hyperactivity Disorder (ADHD). The target subjects are healthy male and
female children aged 6 to 12 years, inclusive, with a diagnosis of ADHD. A total of 120
subjects will be randomized across approximately 30 US centers to one of four treatment
groups.
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Page last updated: 2017-09-19
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