II. A Randomised Controlled Trial of Prophylactic Neuroleptic Treatment

1986 ◽  
Vol 148 (2) ◽  
pp. 120-127 ◽  
Author(s):  
T. J. Crow ◽  
J. F. MacMillan ◽  
A. L. Johnson ◽  
E. C. Johnstone
Keyword(s):  
Controlled Trial ◽  
First Episode ◽  
Neuroleptic Treatment ◽  
Duration Of Symptoms ◽  
Loss To Follow Up ◽  
Neuroleptic Medication ◽  
Duration Of Illness ◽  
Extended Duration ◽  
Randomised Controlled

Out of 253 patients fulfilling criteria for a first episode of schizophrenic illness, 120 entered a randomised placebo-controlled trial of maintenance neuroleptic medication on discharge; they were followed to relapse or loss to follow-up, for two years or to the end of the study. Of those on active medication, 46% relapsed, as did 62% of those on placebo; the most important determinant of relapse was duration of illness prior to starting neuroleptic medication. This finding might be because extended duration of symptoms before admission is more likely to be present in illnesses which in any case will have poor prognosis, or because susceptibility to relapse is reduced by early institution of treatment. The study provides no data on which a decision between these alternative explanations can be based.

scholarly journals Feasibility study on recruitment in general practice for a low back pain online information study (part of the ADVIN Back Trial)

2020 ◽  
Vol 13 (1) ◽  
Author(s):  
Allan Riis ◽  
Michael Skovdal Rathleff ◽  
Jan Hartvigsen ◽  
Janus Laust Thomsen ◽  
Tamana Afzali ◽  
...  
Keyword(s):  
General Practice ◽  
Low Back Pain ◽  
Back Pain ◽  
Randomised Controlled Trial ◽  
Web Application ◽  
Controlled Trial ◽  
Low Back ◽  
Loss To Follow Up ◽  
Randomised Controlled

Abstract Objective In a future full-scale randomised controlled trial, we plan to compare satisfaction with a standard website versus satisfaction with a participatory driven web-application. The participatory driven web-application may facilitate the delivery of targeted evidence-based advice and information to patients with low back pain in general practice (ClinicalTrials.gov Identifier: NCT03088774). This feasibility study is intended to inform a future randomised controlled trial. The aim is to report on the lessons learned from recruitment to report on reasons for loss to follow-up. Results We recruited 12 women and 8 men from two general practices with each practice recruiting for 3 months. Full follow-up data was available in only three patients (15%). Based on the high loss to follow-up, we do not consider it feasible to conduct the full-scale confirmatory trial as planned. Modifying inclusion criteria to include only patients expressing an interest in using online health information or randomising patients directly at the general practice, supporting them in accessing the web-application, and letting patients respond with their immediate satisfaction may improve the speed of recruitment and follow-up rates. Furthermore, the participatory driven web-application can be included in a larger multi-faceted intervention, making the combined intervention seem more relevant to study participants.

scholarly journals Estimating psychological treatment effects from a randomised controlled trial with both non-compliance and loss to follow-up

2003 ◽  
Vol 183 (4) ◽  
pp. 323-331 ◽  
Author(s):  
G. Dunn ◽  
M. Maracy ◽  
C. Dowrick ◽  
J. L. Ayuso-Mateos ◽  
O. S. Dalgard ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Psychological Intervention ◽  
Psychological Treatment ◽  
Causal Effect ◽  
Controlled Trial ◽  
Loss To Follow Up ◽  
Average Causal Effect ◽  
Trial Subject ◽  
Randomised Controlled

BackgroundThe Outcomes of Depression International Network (ODIN) trial evaluated the effect of two psychological interventions for the treatment of depression in primary care. Only about half of the patients in the treatment arm complied with the offer of treatment, prompting the question: ‘what was the effect of treatment in those patients who actually received it?’AimsTo illustrate the estimation of the effect of receipt of treatment in a randomised controlled trial subject to non-compliance and loss to follow-up.MethodWe estimated the complier average causal effect (CACE) of treatment.ResultsIn the ODIN trial the effect of receipt of psychological intervention (an average of about 4 points on the Beck Depression Inventory) is about twice that of offering it.ConclusionsThe statistical analysis of the results of a clinical trial subject to noncompliance to allocated treatment is now reasonably straightforward through estimation of a CACE and investigators should be encouraged to present the results of analyses of this type as a routine component of a trial report.

scholarly journals Augmentation of clozapine with ECT: a retrospective case analysis

2020 ◽  
pp. 1-6
Author(s):  
John Lally ◽  
Emily Breese ◽  
Mugtaba Osman ◽  
Cai Hua Sim ◽  
Hitesh Shetty ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Meta Analysis ◽  
Retrospective Case ◽  
Clozapine Treatment ◽  
Duration Of Illness ◽  
Maintenance Ect ◽  
The Mean ◽  
Randomised Controlled ◽  
Clinical Global Impression Improvement

Abstract Objective: We sought to assess the effectiveness of clozapine augmentation with Electroconvulsive therapy (ECT) (C+ECT) in patients with clozapine-resistant schizophrenia. Methods: We conducted a retrospective review of electronic health records to identify patients treated with C+ECT. We determined the response to C+ECT and the rate of rehospitalisation over the year following treatment with C+ECT. Results: Forty-two patients were treated with C+ECT over a 10-year period. The mean age of the patients at initiation of ECT was 46.3 (SD = 8.2) years (range 27–62 years). The mean number of ECTs given was 10.6 (SD = 5.3) (range 3–25) with the majority receiving twice weekly ECT. Seventy-six per cent of patients (n = 32) showed a Clinical Global Impression-Improvement (CGI-I) score of ≤3 (at least minimally improved) following C+ECT. The mean number of ECT treatments was 10.6 (SD = 5.3) (range 3–25) with the majority receiving twice weekly ECT. Sixty-four per cent of patients experienced no adverse events. Response to C+ECT was not associated with gender, age, duration of illness or duration of clozapine treatment. Seventy-five per cent of responders remained out of hospital over the course of 1-year follow-up, while 70% of those with no response to C+ECT were not admitted to hospital. Three patients received maintenance ECT, one of whom was rehospitalised. Conclusion: This study lends support to emerging evidence for the effectiveness of C+ECT in clozapine-resistant schizophrenia. These results are consistent with the results of a meta-analysis and the only randomised controlled trial (RCT) of this intervention. Further RCTs are required before this treatment can be confidently recommended.

A single-blind, randomised controlled trial on the effects of lithium and quetiapine monotherapy on the trajectory of cognitive functioning in first episode mania: A 12-month follow-up study

2016 ◽  
Vol 31 ◽  
pp. 20-28 ◽  
Author(s):  
R. Daglas ◽  
S.M. Cotton ◽  
K. Allott ◽  
M. Yücel ◽  
C.A. Macneil ◽  
...  
Keyword(s):  
Bipolar Disorder ◽  
Randomised Controlled Trial ◽  
Lithium Treatment ◽  
Controlled Trial ◽  
Cognitive Change ◽  
Performance Outcomes ◽  
First Episode ◽  
Randomised Controlled ◽  
Single Blind

AbstractBackgroundCognitive deficits have been reported during the early stages of bipolar disorder; however, the role of medication on such deficits remains unclear. The aim of this study was to compare the effects of lithium and quetiapine monotherapy on cognitive performance in people following first episode mania.MethodsThe design was a single-blind, randomised controlled trial on a cohort of 61 participants following first episode mania. Participants received either lithium or quetiapine monotherapy as maintenance treatment over a 12-month follow-up period. The groups were compared on performance outcomes using an extensive cognitive assessment battery conducted at baseline, month 3 and month 12 follow-up time-points.ResultsThere was a significant interaction between group and time in phonemic fluency at the 3-month and 12-month endpoints, reflecting greater improvements in performance in lithium-treated participants relative to quetiapine-treated participants. After controlling for multiple comparisons, there were no other significant interactions between group and time for other measures of cognition.ConclusionAlthough the effects of lithium and quetiapine treatment were similar for most cognitive domains, the findings imply that early initiation of lithium treatment may benefit the trajectory of cognition, specifically verbal fluency in young people with bipolar disorder. Given that cognition is a major symptomatic domain of bipolar disorder and has substantive effects on general functioning, the ability to influence the trajectory of cognitive change is of considerable clinical importance.

scholarly journals Crisis card following self-harm: 12-month follow-up of a randomised controlled trial

2005 ◽  
Vol 187 (2) ◽  
pp. 186-187 ◽  
Author(s):  
Jonathan Evans ◽  
Mark Evans ◽  
H. Gethin Morgan ◽  
Alan Hayward ◽  
David Gunnell
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
First Episode ◽  
Telephone Consultation ◽  
Self Harm ◽  
Randomised Controlled ◽  
Modest Effect

SummaryNo intervention has been shown to be effective in preventing repetition of self-harm. In the 6-month follow-up of a large randomised controlled trial, we previously reported no effectiveness of the provision of a card offering 24-h crisis telephone consultation on repetition of self-harm. However, there was a possible benefit among those presenting following a first episode (OR=0.64, 95% CI 0.34–1.22). Here we report the 12-month follow-up of the trial. The results confirm no overall benefit of the intervention (OR=1.19, 95% CI 0.85–1.67). Among those with a first episode of self-harm, the possible benefit of the intervention had diminished (OR=0.89, 95% CI 0.52–1.52), although a modest effect cannot be excluded.

Sign in / Sign up

Export Citation Format

Share Document