MDD studies turn on clinician-rated scales, participant questionnaires between visits and careful follow-up of safety signals. Capture holds all three in one study with one audit trail. Build and test the whole protocol in the free sandbox, no credit card, and pay only when you go live.
Free sandbox · No credit card · 21 CFR Part 11 aligned
| Assessment | Screen | Baseline | Wk 1 | Wk 2 | Wk 4 | Wk 6 | Wk 8 |
|---|---|---|---|---|---|---|---|
| Clinician-rated depression scale | |||||||
| Suicidality assessment | |||||||
| PHQ-9 (participant phone) | |||||||
| Adverse events | |||||||
| Concomitant medications |
x = completed at this visit
What an MDD trial needs from its EDC
The study data
Major depressive disorder trials share a recognisable shape. A screening visit confirms the diagnosis and the severity threshold, records the current episode and the history of earlier ones, and lists the antidepressants the person has already tried. A baseline visit sets the reference score on a clinician-rated scale. Follow-up visits repeat that scale every one to several weeks, alongside participant questionnaires, safety assessments and a running list of concomitant medications. Longer designs add a randomized withdrawal or relapse-prevention phase, and an open-label extension for long-term safety.
The endpoint is usually a change in a rating-scale score, which is a judgement-heavy measurement made by a person. That is where data quality is won or lost. Two raters can score the same interview differently, and an item left blank or entered in the wrong field changes the total. An EDC cannot fix the interview, but it can make the data around it trustworthy: every item is a typed field with allowed values, every change is logged with the old value, new value, user and reason, and the person who entered a score is recorded for every visit. When the statistician later asks whether a score was altered after the visit, the answer is in the record rather than in someone's memory.
The second weak spot is time. Depression scales ask about a defined recall period, usually the past week or two, so a visit that happens outside its window changes what the score means. Capture lets you define visit windows in the schedule, so out-of-window visits are visible when they happen rather than at database lock. The wider picture for psychiatric designs, including placebo-response controls, is covered in EDC for psychiatry clinical trials; this page goes narrower, on the data an MDD protocol specifically needs.
A clinician-rated scale such as the Hamilton Depression Rating Scale belongs on a site eCRF form completed at the visit. A self-report questionnaire such as the PHQ-9 belongs with the participant, who can answer on a phone. Both land in the same study database, so the same person's clinician score and self-report score sit in one export, not in two files joined by hand later. See clinician-rated and patient-reported outcomes for how the categories differ.
Evening diary
Question 3 of 8
How would you rate your fatigue today?
0 = no fatigue, 10 = worst imaginable
Protocol to build
| Protocol element | What the data looks like | Where it lives in Capture |
|---|---|---|
| Eligibility and severity threshold | Diagnosis, current episode, baseline score cut-off | Screening form with edit checks; eligibility screening template |
| Prior treatment history | Each antidepressant tried, dose, duration, response | Repeating rows on a history form; medical history template |
| Primary rating scale | Item scores at each visit, entered by a named rater | Visit eCRF form per assessment, scheduled across the visit plan |
| Self-report between visits | PHQ-9 style items sent to the phone | ePRO task with reminders and completion windows |
| Suicidality follow-up | Prospective assessment at every visit | Visit form; C-SSRS template; edit check to prompt follow-up |
| Safety | Adverse events, severity, seriousness | Adverse event form with an SAE workflow |
| Concomitant medications | Changes to background treatment | Concomitant medications template, repeating rows |
| Randomized, blinded design | Arm allocation, blinded raters | Randomization in the same system; blinded roles never receive arm values |
Scale wording is yours to supply. Licensed instruments stay with your study documents; Capture does not supply or verify instrument licences, and licence controls exist only on participant questionnaires.
Upload the protocol, let the AI draft visits and forms for you to review, and test it with sample data. Free sandbox, no credit card.
Safety and suicidality
Prospective suicidality assessment at every visit is standard in antidepressant trials, and the data has to be both complete and visible. In Capture the assessment is a visit form, so a missed one shows as an open item rather than as a quiet gap. An edit check can raise an automatic query when an answer breaks a rule you set, for example a positive response on a suicidal ideation item or a PHQ-9 item answered above zero, so the site is prompted to follow up and document what happened. Be clear in your protocol about what this is: a data-management prompt that makes the response visible, not a clinical alerting system. Clinical safety procedures remain the investigator's, written in the protocol.
Adverse events use the same structure as any other trial: onset, severity, seriousness, relationship, action taken and outcome, with a separate sign-off path for serious events. The adverse event reporting software page describes the workflow. In MDD trials, worsening of depression and emerging suicidal thoughts can look like both an efficacy measure and a safety event, so define in the protocol and the data management plan how each is recorded, and build the forms to match. A data management plan template is a useful place to write those rules down before the first participant.
For blinded studies, role design matters. Blinded roles never receive treatment-arm values, enforced at the database level by masked views rather than by hiding a column in the interface. That lets a blinded rater and a monitor work in the same study as an unblinded statistician. If your design stratifies by baseline severity or prior treatment response, see randomization without a CRO and clinical trial platform with randomization.
Build sequence
A realistic order of work for a sponsor or investigator team.
Upload the protocol (PDF, DOCX or DOC) and let the AI study builder propose the visit schedule and forms. Nothing is saved until a person reviews it. Or start from the template library.
Set ranges on item scores, rules on the screening threshold and visit windows around each scheduled week.
Create the PHQ-9 style task with reminders and a completion window. Participants answer through a secure link on their own phone, no app.
Enter practice participants through a full schedule, trigger every edit check and read the audit trail. Show the principal investigator the working build.
Forms move from draft to approved and approved forms lock for live use. Real participants start the paid live phase of the study.
Design variants
Different MDD designs stress different parts of the build. Adjunctive designs add a study drug to an ongoing antidepressant, so the background medication list is central and must be reviewed at every visit; repeating rows on the concomitant medications form, each with its own audit trail, fit that need. Treatment-resistant designs need a clean record of prior treatment failures, which is a history form with one row per previous trial, not a free-text note. Relapse-prevention designs have a stabilisation phase followed by randomized withdrawal, which means two epochs with different visit plans for the same participant; the arms and epochs structure in the schedule handles that.
Longer designs also raise retention, and retention in depression studies is a known challenge. Reminders by email or SMS and completion windows help participants keep up with between-visit questionnaires, and the compliance view shows by study, country and site who is falling behind so the team can reach out early. For multi-site studies, QR-code enrolment, site-level participant numbering and a separate site coordinator portal keep sites organised; see multi-site clinical trial management.
Phase does not change the build much. Capture is used from Phase 1 through Phase 3, so a first-in-patient study and a pivotal MDD program run on the same platform, the difference being the number of sites and the size of the monitoring plan. If you are planning a registrational study, Phase 3 EDC covers the multi-site specifics.
Before first participant
Rating scales and questionnaires licensed through their rights holders, with terms filed in the study documents.
Who scores which visit, and how the audit trail will show it.
The clinical response sits in the protocol; the edit check only prompts follow-up.
Each scheduled week has an allowed range matching the recall period of the scale.
Blinded rater, monitor and statistician each see only what they should.
CSV or Excel with the data dictionary opened in the statistics package.
Yes. A clinician-rated scale is built as a site eCRF form with one typed field per item, scheduled across the visit plan. The licence for any published scale stays with your study documents; Capture does not supply instrument wording or verify licences, and licence controls apply only to participant questionnaires.
Yes. The questionnaire opens from a secure link in the phone browser, with no app to install, reminders and a completion window you control.
As a visit form at every scheduled visit. An edit check can raise an automatic query when an answer breaks a rule you define, prompting site follow-up. It is a data-management prompt; clinical safety procedures stay with the investigator and the protocol.
Yes. Blinded roles never receive treatment-arm values, enforced by masked database views, and randomization is part of the same platform.
Yes. Capture is suitable for Phase 1, 2 and 3 studies, and multi-site Phase 3 work uses site-level numbering, a site coordinator portal and by-site exports.
Capture provides Part 11-aligned controls: a field-level audit trail, electronic signatures and role-based access. Compliance is shared with the sponsor's own validated use of the system. This is not legal advice.
The sandbox is free with every feature, no credit card and no time limit. You pay only once you go live with real participants. Pricing is not published on the site, so ask for terms for your study.
The psychiatry page covers the whole area, including other conditions. This page is specific to MDD: prior treatment history, relapse-prevention epochs, the HAM-D and PHQ-9 pairing and suicidality follow-up.
Keep exploring
EDC for psychiatry clinical trials
The wider psychiatry view.
Hamilton Depression Scale eCRF
A clinician-rated form structure.
PHQ-9 eCRF template
Participant-reported depression measure.
C-SSRS eCRF template
Suicidality assessment form.
ePRO software for clinical trials
Questionnaires on participants' phones.
EDC for CNS and neurology trials
Neurology-side designs.
Free sandbox with every feature. No credit card, and you pay only when you go live.