A Controlled Trial of Thiopropazate Dihydrochloride (Dartalan), Chlorpromazine and Occupational Therapy in Chronic Schizophrenics

Hamilton, Max; Smith, Arthur L.; Lapidus, H E; Cadogan, E P

doi:10.1192/bjp.106.442.40

Cited by 46 publications

(3 citation statements)

References 11 publications

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“…However, the overall number of trials reporting the randomization and allocation methods was low (18% and 10%, respectively). Also, eight trials were not double-blinded or single-blinded with external raters, four of them compared patients using pharmacological vs. non-pharmacological treatments (ECT, insulin therapy or psychotherapy) [31], [33], [37], [38]. One used a no-treatment arm [39], one was initially double-blinded but patients and physicians discovered the assignment because the pills taken differed in color, size and quantity for each arm [32], one had patients in one group doing weekly blood tests while the other group did not [35]; and in another study, patients knew their assignment groups [36].…”

Section: Resultsmentioning

confidence: 99%

Changes in Clinical Trials Methodology Over Time: A Systematic Review of Six Decades of Research in Psychopharmacology

2010

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BackgroundThere have been many changes in clinical trials methodology since the introduction of lithium and the beginning of the modern era of psychopharmacology in 1949. The nature and importance of these changes have not been fully addressed to date. As methodological flaws in trials can lead to false-negative or false-positive results, the objective of our study was to evaluate the impact of methodological changes in psychopharmacology clinical research over the past 60 years.Methodology/Principal FindingsWe performed a systematic review from 1949 to 2009 on MEDLINE and Web of Science electronic databases, and a hand search of high impact journals on studies of seven major drugs (chlorpromazine, clozapine, risperidone, lithium, fluoxetine and lamotrigine). All controlled studies published 100 months after the first trial were included. Ninety-one studies met our inclusion criteria. We analyzed the major changes in abstract reporting, study design, participants' assessment and enrollment, methodology and statistical analysis. Our results showed that the methodology of psychiatric clinical trials changed substantially, with quality gains in abstract reporting, results reporting, and statistical methodology. Recent trials use more informed consent, periods of washout, intention-to-treat approach and parametric tests. Placebo use remains high and unchanged over time.Conclusions/SignificanceClinical trial quality of psychopharmacological studies has changed significantly in most of the aspects we analyzed. There was significant improvement in quality reporting and internal validity. These changes have increased study efficiency; however, there is room for improvement in some aspects such as rating scales, diagnostic criteria and better trial reporting. Therefore, despite the advancements observed, there are still several areas that can be improved in psychopharmacology clinical trials.

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Section: Resultsmentioning

confidence: 99%

Changes in Clinical Trials Methodology Over Time: A Systematic Review of Six Decades of Research in Psychopharmacology

2010

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“…Thus, the ability to generalize between disparate studies is very limited. Although the focus of this article is the clinical and social functioning of the schizophrenic patient in the community rather than the hospital management of the acute episode, it should be remembered that the efficacy of the drug therapy of acute schizophrenia varies as a function of the nature of the support provided by the milieu (Rathod 1958;Hamilton et al 1960Hamilton et al , 1963Goldsmith and Drye 1963).…”

Section: Evidence For Drug-psychosocial Interactionsmentioning

confidence: 99%

Interactions Between Drug and Psychosocial Therapy in Schizophrenia

Falloon

Liberman

1983

Schizophrenia Bulletin

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Research on the interactions between drug and psychosocial interventions in the community management of schizophrenia is related to a stress/vulnerability conception of this disorder. Earlier findings that psychosocial treatments were not efficacious in the community management of schizophrenia are contrasted with promising recent data from psychosocial treatments aimed at reducing environmental stressors and promoting interpersonal competence. Family interventions and social skills training may contribute significantly to the clinical and social outcomes achieved by optimal pharmacotherapy.

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“…Thiopropazate hydrochloride (Dartalan) is chemically described as 10-(3[4-(2-acetyoxyethyl)piperazin-1-yl]propyl)-2chlorophenothiazine dihydrochloride and is a phenothiazine structurally closely related to chlorpromazine. It has been reported to be of value in schizophrenia (Hamilton et al, 1960). Reports on its effectiveness in controlling choreiform movements have been confined to Huntingdon's chorea (Mathews, 1958;Bruyn, 1962;Lyon, 1962) apart from, so far as we can trace, one case each of non-hereditary chorea (Lyon, 1962), probable senile chorea with polycythaemia (Heathfield, 1968), and Sydenham's chorea activated by oral contraceptives (Lewis and Harrison, 1969).…”

Section: Introductionmentioning

confidence: 95%

Thiopropazate Hydrochloride in Persistent Dyskinesia

Singer¹,

Cheng²

1971

BMJ

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One patient developed severe haematemesis needing inpatient therapy and had to be withdrawn from the trial. In retrospect it was clear that he should not have been admitted to the trial because he had a history of peptic ulceration. DiscussionControlled trials of treatment in Bell's palsy are difficult to perform because of delay in starting therapy which is likely to prejudice the result. For this reason the patients were subdivided into early and late groups. Sixty-six started treatment on the first or second day of paralysis and 120 on the third or fourth days. The results of earlier treatment were indeed better, though both groups showed benefit. However, in very severe attacks the major damage may be done within the first few hours and treatment should be started at once.It has previously been shown that the outcome in untreated Bell's palsy becomes worse with increasing age (Langworth and Taverner, 1963) so the patients were further subdivided into young and older groups. There were 104 patients in the young group and 82 in the older group. The expected difference was observed, but in the whole series the mean age of the patients who developed denervation was 44-6 years for the corticotrophin group and 43 9 years for the prednisolone group.Assessment of the result of treatment is a difficult problem even if very elaborate methods are used. The presence or absence of denervation can be determined by the appearance of associated movements (Langworth and Taverner, 1963), and this is the strictest criterion available. The results now reported are based almost entirely on this finding. We are well aware of the unreliability of subjective estimates of the difference in movement of the two sides of the face, but the statistically significant differences reported here are considerable and it is unlikely that observer error is responsible. The actual assessments of recovery in the severely denervated patients receiving corticotrophin mentioned above were 10%, 15%, 10%, 10%, 15%, and 15%, while all who took prednisolone were assessed at 50% recovery or above.We had hoped to show that corticotrophin injections gave better results than oral prednisolone if only because a previous trial of cortisone for Bell's palsy gave a negative result (Tavemer, 1954). In retrospect it is clear that the 1954 trial was intadequately planned to produce a reliable result. The treatment was started far too late to be effective, the dose of cortisone was too low, and the number of patients tested was too small.At present we believe that oral prednisolone is the treatment of choice in Bell's palsy and should be given in full doses from the day of onset. The small risk of serious side effects is acceptable in view of the significant reduction in the incidence of severe denervation. ReferencesJonsson, B., Reis, G. von, and Sahlgren, E. (1951 Journal, 1971, 4, 22-25 Summary Thiopropazate (Dartalan) was found to be significantly more effective than a placebo in relieving dyskinesia in 23 patients with functional psychosis and persisten...

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A Controlled Trial of Thiopropazate Dihydrochloride (Dartalan), Chlorpromazine and Occupational Therapy in Chronic Schizophrenics

Cited by 46 publications

References 11 publications

Changes in Clinical Trials Methodology Over Time: A Systematic Review of Six Decades of Research in Psychopharmacology

Changes in Clinical Trials Methodology Over Time: A Systematic Review of Six Decades of Research in Psychopharmacology

Interactions Between Drug and Psychosocial Therapy in Schizophrenia

Thiopropazate Hydrochloride in Persistent Dyskinesia

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