Wilson 2003.

Study characteristics
Methods	Design: multi‐phase double‐blind randomised controlled trial Prerandomisation phase Phase 1: acute treatment with sertraline 50 to 200 mg (8 weeks) Phase 2: continuation treatment with sertraline 50 to 200 mg (16 to 20 weeks) Duration post randomisation: 100 weeks Aim: to examine the efficacy of sertraline in preventing recurrence of depression among older people living in the community
Participants	Country: UK Setting: community older people from a community survey conducted at the same time as the trial; 20 general practices and 4 old age psychiatry teams Type of AD: sertraline Duration of antidepressant treatment prerandomisation: 24 to 28 weeks Duration of antidepressant treatment post stabilisation: 16 to 20 weeks Number of participants: 254 entered treatment phases 1 and 2; 113 completed phase 2 Total numbers of randomised participants: 113 (57 placebo, 56 antidepressant) Primary diagnosis: major depressive disorder First episode of depression: 73.6% placebo, 71.4% antidepressant Gender distribution (male): placebo 66%, sertraline 34% Mean age, years (SD): placebo 76.8 (7.0), sertraline 76.6 (6.6) Severity of depressive symptoms at randomisation, mean (SD) ‐ HDRS score: placebo 20.3 (3.3), sertraline 20.7 (3.7) ‐ MADRS score: placebo 26.0 (5.4), sertraline 26.48 (6.5) Inclusion criteria ‐ ≥ 65 years of age ‐ psychiatric diagnoses: Geriatric Mental State AGECAT depression ≥ level 3, DSM–III–R diagnoses of major depressive disorder, HDRS 17‐item score ≥ 18 at entry to phase 1 Definition of response: 50% reduction in baseline HDRS by Week 8 and HDRS score ≤ 10 had to be maintained for 4 weeks Exclusion criteria ‐ MMSE score ≤ 11 ‐ severe and unstable physical illness ‐ clinically significant alcohol misuse ‐ significant suicidal or delusional experiences ‐ concomitant drug treatment, including other psychotropic drugs, warfarin, and anticonvulsants
Interventions	Intervention 1: placebo Tapering scheme: not described Intervention 2: sertraline. All participants were maintained on their final therapeutic dosage during the randomised, controlled phase of the study, with the exception of those treated with 200 mg. In the latter cases, the maintenance dosage was decreased from 200 mg to 150 mg
Outcomes	Primary outcome ‐ recurrence Definition of recurrence: HDRS score ≥13 as well as meeting DSM–III–R criteria for major depressive disorder as determined by a trained psychiatrist Secondary outcome: none reported
Notes	Funding: study supported by a grant from the pharmaceutical industry COI: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Comment: computer random number generator was used Quote: “a computer‐generated randomisation list was provided by Pfizer Ltd. The list was stratified by dosage and used to produce numbered containers for the identical capsules of either sertraline or placebo”
Allocation concealment (selection bias)	Low risk	Comment: independent trialist was responsible for allocation concealment Quote: “a computer‐generated randomisation list was provided by Pfizer Ltd. A company independent of the sponsor and trialist was responsible for packaging the trial drugs and randomisation. The list was stratified by dosage and used to produce numbered containers for the identical capsules of either sertraline or placebo. Codes were maintained in opaque, sealed envelopes. They were broken on trial completion, after locking the study database. External research auditors maintained the security of the codes”
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Comment: double‐blind described; unlikely that the code could have been broken Quote: “double‐blind"; "identical capsules"; "codes were maintained in opaque, sealed envelopes"; "they were broken on trial completion, after locking the study database”; "external research auditors maintained the security of the codes"
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Comment: blinding to outcome assessment ensured; unlikely that blinding could have been broken Quote: “research staff conducted follow‐up assessments. External research auditors maintained the security of the codes, and verified data collection and cleaning"
Incomplete outcome data (attrition bias) All outcomes	Low risk	All missing data accounted for and reasons for dropouts reported
Selective reporting (reporting bias)	High risk	Comment: the study report fails to include results for adverse events and withdrawal symptoms that would be expected to have been reported for such a study
Other bias	Unclear risk	Comment: a grant from the pharmaceutical industry

AD: antidepressant.

AE: adverse event.

AGECAT: Automated Geriatric Examination for Computer‐Assisted Taxonomy.

BAI: Beck Anxiety Inventory.

BDI: Beck Depression Inventory.

BHS: Beck Hopelessness Scale.

bid: twice a day.

BNF: British National Formulary.

CBASP: Cognitive‐Behavioural Analysis System of Psychotherapy.

CBT: cognitive‐behavioural therapy.

CESD: Center for Epidemiological Studies Depression Scale.

CGI: Clinical Global Impressions Scale.

CGI‐I: Clinical Global Impressions‐Improvement Scale.

CGI‐S: Clinical Global Impressions‐Severity Scale.

CIDI: Composite International Diagnostic Interview.

DESS: Discontinuation‐Emergent Signs and Symptoms Scale.

DSSI: Discontinuation Symptoms Severity Index.

DIP: disability and impact profile.

DSM‐III‐R: Diagnostic and Statistical Manual of Mental Disorders, Third Edition.

DSM‐IV (‐TR): Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision.

ECG: electrocardiogram.

ECT: electroconvulsive therapy.

EQ‐5D: EuroQoL Group Quality of Life Questionnaire based on 5 dimensions.

ESF: End‐State Functioning.

GAD: generalised anxiety disorder.

GAS: Goal Attainment Scale.

GDS: Geriatric Depression Scale.

GP: general practitioner.

GRID: GRID–Hamilton Rating Scale for Depression.

HAM‐A: Hamilton Anxiety Rating Scale.

HAM‐D or HDRS: Hamilton Depression Rating Scale.

IDS‐C: Inventory for Depressive Symptomatology‐Clinician.

IDS‐SR: Inventory of Depressive Symptomatology–Self‐Report.

IPT: interpersonal therapy.

IGR: interquartile range.

IPT: Interpersonal psychotherapy.

LIFE: Longitudinal Internal Follow‐up Evaluation.

MADRS: Montgomery–Åsberg Depression Rating Scale.

MAOI: monoamine oxidase inhibitor.

MBCT: mindfulness‐based cognitive therapy.

MDD: major depressive disorder.

MDE: major depressive episode.

MINI: mini international neuropsychiatric interview.

MMSE: Mini‐Mental State Examination.

NICE: National Institute of Clinical Excellence.

OCD: obsessive‐compulsive disorder.

PCT: preventive cognitive therapy.

PDSS: Panic Disorder Severity Scale.

PGI‐I: Patient Global Impressions of Improvement Scale.

PTSD: posttraumatic stress disorder.

QIDS: Quick Inventory of Depressive Symptomatology.

Q‐LES‐Q: Quality of Life Enjoyment and Satisfaction Questionnaire.

RCT: randomised controlled trial.

RDC: Research Diagnostic Criteria.

SAR‐SR: Social Adjustment Scale‐Self‐Report.

SCID‐I: Structured Clinical Interview for DSM‐IV Axis I Disorders.

SD: standard deviation.

SE: standard error.

SF‐36: Short‐Form Health Survey 36.

SNRI: serotonin and norepinephrine reuptake inhibitor.

SQ‐SS: Symptom Questionnaire Somatic Subscale.

SSRI: selective serotonin reuptake inhibitor.

TCA: tricyclic antidepressant.

TESS: Treatment‐Emergent Symptoms Scale.

TiC‐P: Treatment Inventory of Costs in Patients.

WHO QoL: World Health Organization Quality of Life.

WHO QoL‐BREF: World Health Organization Cross‐Cultural Comparisons of Quality of Life.