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The first 100 patients in the SUN(^_^)D trial (strategic use of new generation antidepressants for depression): examination of feasibility and adherence during the pilot phase.

ABSTRACT: Initial glitches and unexpected inconsistencies are unavoidable in the early stage of a large, multi-centre trial. Adaptive modifications of the trial's protocol and operational procedures to ensure its smooth running are therefore imperative. We started a large pragmatic, multi-centre, assessor-blinded, 25-week trial to investigate the optimal first- and second-line treatments for untreated episodes of nonpsychotic major depression in 2010 [Strategic Use of New generation antidepressants for Depression, abbreviated SUN(^_^)D] and would like to herein report an examination of the trial's feasibility and adherence among the first 100 participants.We examined the participants' characteristics, the treatments that were allocated and received during each step of the trial, and the quality of the outcome assessments among the first 100 patients enrolled in the SUN(^_^)D trial.Of the 2,743 first-visit patients who visited the two collaborating centres between December 2010 and July 2011, 382 were judged as potentially eligible, and 100 of these patients provided written informed consent. These patients represented the whole spectrum of mild to very severe depression. Of the 93 patients who had reached Week 3 of the study by the end of July 2011, one withdrew consent for both the treatment and the assessment, and eight withdrew consent for the treatment only. Altogether, the primary outcomes were successfully assessed in 90 (96.8%) of the patients at Week 3. Of the 72 patients who had reached Week 9, three withdrew consent for the treatment, but 70 were successfully interviewed (97.2%). Of the 32 patients who had reached Week 25, 29 (90.5%) were successfully followed up. The inter-rater reliability of the assessments of the primary outcomes was nearly perfect and their successful blinding was confirmed. Minor modifications and clarifications to the protocol were deemed necessary.Given the satisfactory feasibility and adherence to the study protocol and the minor modifications that were necessary, we conclude that the data obtained from the first 100 patients can be safely included in the main study. We now intend to accelerate the study by recruiting more collaborating centres and clinics/hospitals.ClinicalTrials.gov identifier: NCT01109693.

SUBMITTER: Shimodera S

PROVIDER: S-EPMC3409023 | biostudies-literature | 2012 Jun

REPOSITORIES: biostudies-literature

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The first 100 patients in the SUN(^_^)D trial (strategic use of new generation antidepressants for depression): examination of feasibility and adherence during the pilot phase.

Shimodera Shinji S Kato Tadashi T Sato Hirotoshi H Miki Kazuhira K Shinagawa Yoshihiro Y Kondo Masaki M Fujita Hirokazu H Morokuma Ippei I Ikeda Yoshio Y Akechi Tatsuo T Watanabe Norio N Yamada Mitsuhiko M Inagaki Masatoshi M Yonemoto Naohiro N Furukawa Toshi A TA

Trials 20120608

<h4>Background</h4>Initial glitches and unexpected inconsistencies are unavoidable in the early stage of a large, multi-centre trial. Adaptive modifications of the trial's protocol and operational procedures to ensure its smooth running are therefore imperative. We started a large pragmatic, multi-centre, assessor-blinded, 25-week trial to investigate the optimal first- and second-line treatments for untreated episodes of nonpsychotic major depression in 2010 [Strategic Use of New generation ant ...[more]

PMID: 22682213

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Project description:After more than half a century of modern psychopharmacology, with billions of dollars spent on antidepressants annually world-wide, we lack good evidence to guide our everyday decisions in conducting antidepressant treatment of patients with major depression. First we did not know which antidepressant to use as first line treatment. Second we do not know which dosage we should be aiming at with that antidepressant. Because more than half of the patients with major depression starting treatment do not remit after adequate trial with the first agent, they will need a second line treatment. Dose escalation, augmentation and switching are the three often recommended second line strategies but we do not know which is better than the others. Moreover, we do not know when to start considering this second line treatment.The recently published multiple-treatments meta-analysis of 12 new generation antidepressants has provided some partial answers to the first question. Starting with these findings, this proposed trial aims to establish the optimum 1st line and 2nd line antidepressant treatment strategy among adult patients with a non-psychotic unipolar major depressive episode.SUN(^_^)D, the Strategic Use of New generation antidepressants for Depression, is an assessor-blinded, parallel-group, multi-centre randomised controlled trial. Step I is a cluster-randomised trial comparing titration up to the minimum vs maximum of the recommended dose range among patients starting with sertraline. The primary outcome is the change in the Patient Health Questionnaire (PHQ)-9 scores administered by a blinded rater via telephone at week 1 through 3. Step II is an individually randomised trial comparing staying on sertraline, augmentation of sertraline with mirtazapine, and switching to mirtazapine among patients who have not remitted on the first line treatment by week 3. The primary outcome is the change in the PHQ-9 scores at week 4 through 9. Step III represents a continuation phase to Steps I and II and aims to establish longer-term effectiveness and acceptability of the above-examined treatment strategies up to week 25. The trial is supported by the Grant-in-Aid by the Ministry of Health, Labour and Welfare, Japan.SUN(^_^)D promises to be a pragmatic large trial to answer important clinical questions that every clinician treating patients with major depression faces in his/her daily practices concerning its first- and second-line treatments.ClinicalTrials.gov: NCT01109693.

Project description:Depression is one of the most common psychological problems affecting individuals with type 1 diabetes, and it is associated with treatment nonadherence and worse clinical outcomes. The research on treating depression or nonadherence in adults with type 1 diabetes is limited. We adapted an evidence-supported treatment, individual cognitive-behavioral therapy for adherence and depression (CBT-AD), for type 1 diabetes and examined its feasibility, acceptability, and potential for an effect. The pilot study included 9 patients with a DSM-IV diagnosis of major depression, dysthymia, or residual depressive symptoms despite treatment with an antidepressant; a diagnosis of type 1 diabetes per patient self-report; and a glycosylated hemoglobin A1c (HbA1c) level of 8.0% or greater. Patients were referred by their diabetes care providers to a behavioral medicine specialty setting and received 10 to 12 sessions of CBT-AD. Main outcome measures included percent of eligible participants who enrolled in the study, session attendance, independently-rated Montgomery-Asberg Depression Rating Scale (MADRS) score, self-reported adherence to diabetes care activities, and adherence to self-monitoring of blood glucose levels. Data were collected from June 27, 2008, through March 31, 2010. There was a clinically meaningful decrease in depression severity (mean [SD] MADRS score decrease from 26.0 [4.73] to 12.3 [7.37], Cohen d = 2.90), demonstrated improvements in diabetes self-care (increase in blood glucose monitoring from 65.0 [26.72] to 82.7 [22.75], Cohen d = -0.66, and a difference in self-reported percent insulin doses in the past 2 weeks from 77.1 [29.84] to 87.1 [23.6], Cohen d = -0.34), and possible improvement in glycemic control (decrease in HbA1c levels from 9.6 [1.32] to 9.0 [1.04], Cohen d = 0.45). These preliminary results provide evidence for the acceptability, feasibility, and potential utility of CBT-AD for patients with type 1 diabetes and depression. clinicaltrials.gov Identifier: NCT01527981.

Project description:Objective:To investigate the feasibility and potential impact of a pharmacy care intervention, involving motivational interviews among patients with acute coronary syndrome, on adherence to medication and on health outcomes. Methods:This article reports a prospective, interventional, controlled feasibility/pilot study. Seventy one patients discharged from a London Heart Attack Centre following acute treatment for a coronary event were enrolled and followed up for 6?months. Thirty two pharmacies from six London boroughs were allocated into intervention or control sites. The intervention was delivered by community pharmacists face-to-face in the pharmacy, or by telephone. Consultations were delivered as part of the New Medicine Service or a Medication Usage Review. They involved a 15-20?min motivational interview aimed at improving protective cardiovascular medicine taking. Results:At 3?months, there was a statistically significant difference in adherence between the intervention group (M=7.7, SD=0.56) and the control group (M=7.0, SD=1.85), p=0.026. At 6?months, the equivalent figures were for the intervention group M=7.5, SD=1.47 and for the controls M=6.1, SD=2.09 (p=0.004). In addition, there was a statistically significant relationship between the level of adherence at 3?months and beliefs regarding medicines (p=0.028). Patients who reported better adherence expressed positive beliefs regarding the necessity of taking their medicines. However, given the small sample size, no statistically significant outcome difference in terms of recorded blood pressure and low density lipoprotein-cholesterol was observed over the 6?months of the study. Conclusions:The feasibility, acceptability and potentially positive clinical outcome of the intervention were demonstrated, long with a high level of patient acceptability. It had a significant impact on cardiovascular medicine taking adherence. But these findings must be interpreted with caution. The intervention should be tested in a larger trial to ascertain its full clinical utility. Trial registration number:ClinicalTrials.gov identifier: NCT01920009.

Dataset Information

The first 100 patients in the SUN(^_^)D trial (strategic use of new generation antidepressants for depression): examination of feasibility and adherence during the pilot phase.

Publications

The first 100 patients in the SUN(^_^)D trial (strategic use of new generation antidepressants for depression): examination of feasibility and adherence during the pilot phase.

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