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Minocycline as an adjunct for treatment-resistant depressive symptoms: study protocol for a pilot randomised controlled trial.

ABSTRACT: BACKGROUND:Depression is one of the leading causes of disability worldwide. A high proportion of patients do not respond to standard drug treatments. Recent evidence has suggested that anti-inflammatory treatment may have beneficial effects in major depression. Minocycline is a tetracycline antibiotic with good CNS penetration that exerts effects on multiple interacting symptoms implicated in the pathophysiology of mood disorders. Open-label studies have suggested that minocycline is effective as an adjunct drug in improving depressive symptoms. METHODS/DESIGN:This is a multi-centre, 3-month, double-blind, placebo-controlled, pilot trial of minocycline added to treatment as usual for patients suffering from DSM-IV major depressive disorder. This will be a double-blind, randomised, controlled, two parallel-arm study with 20 participants in each arm, giving a total of 40 participants. There will be a screening visit, a randomization visit and four follow-up visits. Clinical assessments using the Hamilton Depression Rating Scale (HAM-D), Clinical Global Impression scale (CGI), Patient Health Questionnaire-9 (PHQ -9) and the Generalised Anxiety Disorder scale (GAD-7) will be carried out at every visit. Side effects checklists will also be undertaken at each visit. Biomarkers (inflammatory cytokines and CRP) will be measured at baseline and at the end of the treatment phase. Minocycline will be started at 100 mg once daily (OD) and will be increased to 200 mg at two weeks. DISCUSSION:Anti-inflammatory treatments have been shown to have some beneficial effects in the treatment of major depressive disorder. The aim of this pilot randomised controlled trial is to establish the degree of improvement in depressive symptoms with the addition of minocycline to treatment as usual. TRIAL REGISTRATION:ClinicalTrials.gov NCT02263872 registered 10 October 2014.

SUBMITTER: Husain MI

PROVIDER: S-EPMC4570147 | biostudies-literature | 2015 Sep

REPOSITORIES: biostudies-literature

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Minocycline as an adjunct for treatment-resistant depressive symptoms: study protocol for a pilot randomised controlled trial.

Husain Muhammad I MI Chaudhry Imran B IB Rahman Raza R RR Hamirani Munir M MM Qurashi Inti I Khoso Ameer B AB Deakin John F W JF Husain Nusrat N Young Allan H AH

Trials 20150915

<h4>Background</h4>Depression is one of the leading causes of disability worldwide. A high proportion of patients do not respond to standard drug treatments. Recent evidence has suggested that anti-inflammatory treatment may have beneficial effects in major depression. Minocycline is a tetracycline antibiotic with good CNS penetration that exerts effects on multiple interacting symptoms implicated in the pathophysiology of mood disorders. Open-label studies have suggested that minocycline is eff ...[more]

PMID: 26374703

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Project description:To address uncertainties prior to conducting a fully powered randomised controlled trial of Morita Therapy plus treatment as usual (TAU) versus TAU alone, or to determine that such a trial is not appropriate and/or feasible.Pilot parallel group randomised controlled feasibility trial.Participants aged ?18 years with Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV major depressive disorder, with or without DSM-IV anxiety disorder(s), recruited from general practice record searches in Devon, UK.We randomised participants on a 1:1 basis stratified by symptom severity, concealing allocation using a secure independent web-based system, to receive TAU (control) or 8-12 sessions of Morita Therapy, a Japanese psychological therapy, plus TAU (intervention).Rates of recruitment, retention and treatment adherence; variance and estimated between-group differences in follow-up scores (on the Patient Health Questionnaire 9 (PHQ-9) (depressive symptoms); Generalised Anxiety Disorder Questionnaire 7 (anxiety symptoms); Short Form 36 Health Survey Questionnaire/Work and Social Adjustment Scale (quality of life); Morita Attitudinal Scale for Arugamama (attitudes)) and their correlation with baseline scores.We recruited 68 participants, 5.1% (95% CI 3.4% to 6.6%) of those invited (34 control; 34 intervention); 64/68 (94%; 95% CI 88.3% to 99.7%) provided 4-month follow-up data. Participants had a mean age of 49 years and mean PHQ-9 score of 16.8; 61% were female. Twenty-four of 34 (70.6%) adhered to the minimum treatment dose. The follow-up PHQ-9 (future primary outcome measure) pooled SD was 6.4 (95% CI 5.5 to 7.8); the magnitude of correlation between baseline and follow-up PHQ-9 scores was 0.42 (95% CI 0.19 to 0.61). Of the participants, 66.7% and 30.0% recovered in the intervention and control groups, respectively; 66.7% and 13.3% responded to treatment in the intervention and control groups, respectively.A large-scale trial of Morita Therapy would require 133 participants per group and is feasible with minor modifications to the pilot trial protocol. Morita Therapy shows promise in treating depression and may provide patients with a distinct alternative to current treatments.ISRCTN17544090; Pre-results.

Project description:BackgroundDespite a high prevalence of antenatal depression in low- and middle-income countries, there is very little evidence for contextually adapted psychological interventions delivered in rural African settings. The aims of this study are (1) to examine the feasibility of procedures for a future fully powered efficacy trial of contextually adapted brief problem solving therapy (PST) for antenatal depression in rural Ethiopia, and (2) to investigate the acceptability, fidelity and feasibility of delivery of PST in routine antenatal care.MethodsDesign: A randomised, controlled, feasibility trial and mixed method process evaluation.ParticipantsConsecutive women attending antenatal clinics in two primary care facilities in rural Ethiopian districts. Eligibility criteria: (1) disabling levels of depressive symptoms (Patient Health Questionnaire (PHQ-9) score of five or more and positive for the 10th disability item); (2) gestational age 12-34 weeks; (3) aged 16 years and above; (4) planning to live in the study area for at least 6 months; (5) no severe medical or psychiatric conditions.InterventionFour sessions of adapted PST delivered by trained and supervised antenatal care staff over a maximum period of eight weeks.Controlenhanced usual care (EUC).Sample sizen = 50. Randomisation: individual randomisation stratified by intimate partner violence (IPV). Allocation: central phone allocation. Outcome assessors and statistician masked to allocation status. Primary feasibility trial outcome: dropout rate. Primary future efficacy trial outcome: change in PHQ-9 score, assessed 9 weeks after recruitment.Secondary outcomesanxiety symptoms, trauma symptoms, intimate partner violence, disability, healthcare costs at 9 weeks; postnatal outcomes (perinatal and neonatal complications, onset of breast feeding, child health) assessed 4-6 weeks postnatal. Other trial feasibility indicators: recruitment, number and duration of sessions attended. Audio-recording of randomly selected sessions and in-depth interviews with purposively selected participants, healthcare providers and supervisors will be analysed thematically to explore the acceptability and feasibility of the trial procedures and fidelity of the delivery of PST.DiscussionThe findings of the study will be used to inform the design of a fully powered efficacy trial of brief PST for antenatal depression in routine care in rural Ethiopia.Trial registrationThe protocol was registered in the Pan-African clinical trials registry, (PACTR): registration number: PACTR202008712234907 on 18/08/2020; URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=9578 .

Project description:Approximately 3% of people receiving opioid substitution therapy (OST) in the UK manage to achieve abstinence from prescribed and illicit drugs within three years of commencing treatment. Involvement of families and wider social networks in supporting psychological treatment may be an effective strategy in facilitating recovery, and this pilot study aimed to evaluate the impact of a social network-focused intervention for patients receiving OST.A two-site, open feasibility trial randomised patients receiving OST for at least 12 months but still reporting illicit opiate use in the past 28 days to one of three treatments: 1) treatment as usual (TAU), 2) Brief Social Behaviour and Network Therapy (B-SBNT)?+?TAU, or 3) Personal Goal Setting (PGS)?+?TAU. The two active interventions consisted of 4 sessions. There were 3 aims: 1) test the feasibility of recruiting OST patients to a trial of B-SBNT, and following them up over 12 months; 2) test the feasibility of training clinicians to deliver B-SBNT; 3) test whether B-SBNT reduces heroin use 3 and 12 months after treatment, and to explore potential mediating factors. The primary outcome for aim 3 was number of days of heroin use in the past month, and a range of secondary outcome measures were specified in advance (level of drug dependence, mental health, social satisfaction, therapist rapport, treatment satisfaction, social network size and support).A total of 83 participants were randomised, and 70 (84%) were followed-up at 12 months. Fidelity analysis of showed that B-SBNT sessions were clearly distinguishable from PGS and TAU sessions, suggesting it was possible to train clinical staff to an adequate level of competence. No significant differences were found between the 3 intervention arms in the primary or secondary outcome measures. Attendance at psychosocial treatment intervention sessions was low across all three arms (44% overall).Patients receiving OST can be recruited into a trial of a social network-based intervention, but poor attendance at treatment sessions makes it uncertain whether an adequate dose of treatment was delivered. In order to achieve the benefits of psychosocial interventions, further work is needed to overcome poor engagement.ISRCTN Trial Registration Number: ISRCTN22608399 . Date of registration: 27/04/2012. Date of first randomisation: 14/08/2012.

Project description:BACKGROUND:Striae gravidarum (stretch marks) are considered the most common connective tissue/skin change in pregnancy. Though not a health issue they can affect women in different ways, for example, cause stress or be an aesthetic or cosmetic concern. Many women use one or more of the commercially available products to try and prevent their development during pregnancy despite the fact that that there is a lack of high-quality evidence to support their use. There is a dearth of studies on the prevention of striae gravidarum and large, robust trials are lacking. Until such time as more products are investigated, much of the knowledge remains anecdotal. This pilot study will evaluate the feasibility of conducting a study to evaluate the effectiveness of a commercially available moisturising oil compared to no treatment for the prevention and reduction in severity of striae gravidarum. METHODS:The definitive study will be a randomised controlled trial to evaluate the effectiveness of a moisturising oil (commercially available moisturising oil) compared to no treatment for the prevention and reduction in severity of striae gravidarum. This protocol is for a pilot randomised trial to evaluate the feasibility of conducting such a study. The pilot study will be a two-arm, unblinded, pragmatic parallel randomised trial with a 1:1 randomisation ratio between control and intervention groups. Women in the intervention group will be asked to apply a moisturising oil to their abdomen during pregnancy, while women in the control group will not use any treatment. It is proposed to recruit 20 primigravida, who are 12-16 weeks pregnant from an Irish Maternity Hospital, in each arm to assess the feasibility of running such a trial. DISCUSSION:This pilot trial will evaluate the feasibility of conducting the main study to evaluate the effectiveness of a moisturising oil (commercially available moisturising oil) compared to no treatment for the prevention and reduction in severity of striae gravidarum. It will potentially initiate the generation of high-quality evidence to guide women in their choice of anti-stretch mark product. TRIAL REGISTRATION:ISRCTN Registry, ISRCTN76992326 . Registered on 14 July 2017.

Dataset Information

Minocycline as an adjunct for treatment-resistant depressive symptoms: study protocol for a pilot randomised controlled trial.

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Minocycline as an adjunct for treatment-resistant depressive symptoms: study protocol for a pilot randomised controlled trial.

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