Bipolar studies swing between short, intensive mania designs and longer depression and relapse-prevention designs, each with its own rating scale, suicidality follow-up and metabolic safety. Capture handles the epochs and the forms in one study. Build and test free, no credit card.
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weeks
Eligibility and washout
Weekly then fortnightly rating
Time to mood episode
What a bipolar trial needs from its EDC
The study data
Bipolar disorder trials fall into three families. Acute mania and mixed-episode studies are short, often 3 weeks, and usually take the change in the Young Mania Rating Scale total score as the primary endpoint. The YMRS has 11 items and a total range of 0 to 60, and responder definitions such as a 50% reduction are common secondary analyses. Bipolar depression studies run longer, commonly 6 to 8 weeks, and use a clinician-rated depression scale, often the MADRS, as the primary. Maintenance and relapse-prevention studies are longer again, with an open-label stabilisation phase followed by randomised withdrawal, and an event endpoint: time to a mood episode, or to an intervention for one.
The clinician-rated scales are interview-based, so rater consistency is the data-quality issue. A manic participant who is sleeping little and speaking fast may be assessed at the same visit by one rater and at the next by another, which adds noise. In Capture each scale is a site eCRF form with one typed field per item, a calculated total shown read-only, and every entry attributed to a named user, with a reason recorded for any later change. Record the rater on the form. For event endpoints, build a mood episode form with onset date, type and the criterion met, so the primary analysis is not reconstructed from adverse event text. The broader psychiatric view, including placebo-response controls, is in EDC for psychiatry clinical trials, and the sister page for unipolar depression is EDC for major depressive disorder.
Timing matters on both ends. Mania ratings are sensitive to the previous few days, so visit windows should be tight in short studies. Maintenance designs carry a different risk: dropout, which in long mood studies often coincides with relapse. Reminders and completion windows on between-visit questionnaires, and the compliance view by site, help the team reach participants who are slipping before they are lost.
Clinician scales such as the Hamilton Depression Rating Scale structure show how an interview-rated depression form is laid out; the same pattern fits the MADRS or YMRS, with the item wording supplied by you under the rights holder's terms. Participant measures such as the PHQ-9 or a mood diary go to the participant's phone. A global impression form anchors the clinical picture. All of them land in one export. See clinician-rated and patient-reported outcomes for the category differences.
Rating summary
Rater
RATERMania rating total
TOTALDerived from item scores, read-only
31 CalculatedChange from baseline
CHGSuicidal ideation since last visit
SIYes: site follow-up required
Protocol to build
| Protocol element | What the data looks like | Where it lives in Capture |
|---|---|---|
| Eligibility and episode type | Diagnosis, current episode (manic, mixed, depressive), baseline score cut-off | Eligibility screening template with edit checks |
| Mania rating | Eleven item scores, total, change from baseline | Site eCRF form per visit; calculated total |
| Depression rating | Item scores and total in bipolar depression designs | Hamilton form structure as a starting layout |
| Global impression | Severity, improvement | CGI template |
| Suicidality follow-up | Prospective assessment each visit | C-SSRS template; edit check to prompt follow-up |
| Mood episode events | Onset, type, criterion met | Custom event form; epoch-aware |
| Metabolic and movement safety | Weight, glucose, lipids, movement ratings | Vital signs and laboratory forms |
| Concomitant mood stabilisers | Lithium, anticonvulsants, antipsychotics with dose changes | Concomitant medications template |
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 with sample data. Free sandbox, no credit card.
Suicidality and safety
Prospective suicidality assessment is routine in psychiatric trials and in bipolar disorder the baseline risk is high. The C-SSRS eCRF template gives a visit-form structure; the instrument itself is the Columbia scale and its wording and terms are yours to obtain. Build it into every scheduled visit so a missed assessment shows as an open item. An edit check can raise an automatic query when an answer breaks a rule you set, prompting site follow-up and documentation. Be explicit in the protocol that this is a data-management prompt, not clinical alerting: the investigator's safety procedures stay in the protocol and the site's standard of care.
Metabolic monitoring is the second pillar. Antipsychotic and mood-stabiliser programmes track weight, BMI, waist circumference, blood pressure, fasting glucose or HbA1c, and lipids, and some add prolactin, thyroid and renal function. If lithium is part of the design, serum levels with their sampling time are a structured field with a range check. Movement-disorder scales are recorded as site forms. Calculated BMI shows read-only, and edit checks raise queries when a value breaks a range; the laboratory results template and adverse event form cover the rest. For serious events see adverse event reporting software.
For blinded studies, role design matters. Blinded roles never receive treatment-arm values, enforced by masked database views rather than hiding a column in the interface, so blinded raters, monitors and an unblinded statistician can work in one study. If you stratify by episode type or prior treatment, see randomization without a CRO and clinical trial platform with randomization.
Build sequence
A realistic order of work.
Acute mania, bipolar depression or maintenance. Each has a different visit plan and primary scale.
Upload the protocol (PDF, DOCX or DOC) and let the AI study builder propose the schedule and forms. Nothing is saved until a person reviews it.
Build stabilisation, randomised and follow-up phases as epochs with their own visit plans.
Ranges on item scores, labs and weight; a suicidality follow-up check; visit windows.
Run practice participants through every epoch, trigger each check and review the audit trail.
Approved forms lock for live use. Real participants start the paid live phase.
Before first participant
Mania, depression and suicidality scales licensed through their rights holders, terms filed in the study documents.
Who scores which visit and how rater calibration is recorded.
The clinical response sits in the protocol; the edit check only prompts follow-up.
How a mood episode, hospitalisation or rescue medication is recorded.
Blinded rater, monitor and statistician each see only what they should.
CSV or Excel with the data dictionary opened in the statistics package.
Yes. Each is built as a site eCRF form with one typed field per item and a calculated total. The licence for any published scale stays with your study documents; Capture does not supply instrument wording or verify licences.
As a visit form at every scheduled visit, starting from the C-SSRS template structure. An edit check can raise an automatic query when an answer breaks a rule you define. It is a data-management prompt; clinical procedures stay with the investigator.
Yes. Arms and epochs let a stabilisation phase, a randomised double-blind phase and follow-up each have their own visit plan, and a mood episode form can capture the event endpoint.
Yes. Blinded roles never receive treatment-arm values, enforced by masked database views, and randomisation is part of the same platform.
Yes, with vital signs and laboratory forms, range edit checks and calculated fields such as BMI.
Yes. Capture is suitable for Phase 1, 2 and 3 studies, with site-level numbering, a site coordinator portal and by-site exports.
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.
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