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Thiothixene (Thiothixene) - Summary



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. Thiothixene is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS).



Thiothixene is a thioxanthene derivative. Specifically, it is the cis isomer of N,N-dimethyl-9-[3-(4-methyl-1-piperazinyl)propylidene]thioxanthene-2-sulfonamide.

THIOTHIXENE is indicated for the following:

Thiothixene capsules are effective in the management of schizophrenia. Thiothixene capsules have not been evaluated in the management of behavioral complications in patients with mental retardation.

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Published Studies Related to Thiothixene

The effect of paroxetine on thiothixene pharmacokinetics. [1997.06]
OBJECTIVE: In this study healthy volunteers received thiothixene with and without a 3-day pretreatment with paroxetine to determine if paroxetine decreased the clearance of thiothixene. METHOD: Ten healthy medication-free volunteers (4 women and 6 men, mean age 38 +/- 12 years) were randomized to receive a single 20 mg oral dose of thiothixene on two separate occasions...

A comparison of thiothixene with chlorpromazine in the treatment of mania. [1988.02]
High potency neuroleptics have been advocated for acute mania because their side effect profile may allow for a more rapid dose escalation and symptom resolution. Low potency neuroleptics have also been advocated because their sedative properties might better calm the acutely agitated manic patient...

Plasma concentrations of thiothixene and clinical response in treatment-resistant schizophrenics. [1987.01]
Plasma concentrations of thiothixene were measured during treatment of 42 treatment-resistant schizophrenic patients. Inter-individual variability was marked even when patients were treated with the same dose or dose regimen... Patients who attained moderate degrees of improvement did so at a median dose of 26 ng/ml, which is within the range of therapeutic plasma concentrations previously reported for thiothixene in similar patients.

Treatment-resistant schizophrenia: controlled study of moderate- and high-dose thiothixene. [1987.01]
Double blind controlled study on fifty treatment-resistant schizophrenic inpatients showed a statistically significant improvement in favour of the high dose group..

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Clinical Trials Related to Thiothixene

Atypical Antipsychotic Treatment Effect On Brain Function In Schizophrenia Measured By FMRI [Completed]
The general aim is to compare the effects of typical and atypical antipsychotic medication on brain structure and function. A parallel group treatment trial will be utilized to compare the effects of the typical antipsychotic thiothixene versus the atypical antipsychotics risperidone (RIS) and olanzapine (OLZ) on brain structure and function in schizophrenia in an effort to determine the neuroanatomic basis for cognitive pathology in schizophrenia and its amelioration by atypical antipsychotic drugs.

Reducing Antipsychotic-Induced Weight Gain in Children With Metformin [Recruiting]
Recent but limited short term studies have shown that Metformin can slow down weight gain in obese children and in children with psychotropic-induced weight gain, two distinct pediatric populations that are at risk for obesity related co-morbid conditions. The purpose of this study is to conduct a long term prospective pilot cohort study to investigate the use of Metformin to prevent or decrease weight gain in two cohorts of children: 1) children with psychotropic induced weight gain on Metformin and 2) children with BMI above the 95th percentile on Metformin. Both study populations will be enrolled in a lifestyle weight management program

CRIC-Visceral Adiposity and Physical Fitness in Chronic Kidney Disease [Recruiting]
Obesity and chronic kidney disease (CKD) are major public health problems. In contrary to observations in general population, higher body mass index in those with pre-existing CKD is associated with lower mortality. Chronic Renal Insufficiency Cohort (CRIC) is an ongoing observational study to examine the consequences of CKD with a particular focus on cardiovascular illness like myocardial infarction (heart attack) and stroke. Among CRIC study participants, the investigators propose to obtain visceral and subcutaneous adiposity and physical fitness measures and study its associations with patient-centered outcomes. This study will help the investigators understand the independent and combined effects of visceral adiposity and physical fitness on cardiovascular disease, renal disease progression and death among those with CKD. Further, it will identify mechanisms that could be targeted to reduce the detrimental effects of visceral adiposity in those with kidney disease.

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Page last updated: 2006-01-31

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