EDC for ketamine-assisted therapy clinics that want research-grade outcomes data

Ketamine and its derivatives are used and studied in depression and related conditions, and some clinics collect outcome data as part of their routine or as a formal study. This page is written for teams that want to capture that data properly: academic groups running randomized trials, clinics running prospective observational studies or outcomes registries, and sponsors of small studies. It does not say what treatment works, recommend any dose, or describe how to deliver treatment. Those decisions belong to your clinical team, your protocol and the regulators and laws that apply to you.

The line between treatment and research matters for data. Routine clinical notes in a records system are not a research dataset: they lack predefined fields, consent for secondary use, query handling and a change history. If you intend to publish, submit to a regulator or pool data with other sites, the study needs its own eligibility criteria, schedule of assessments and consent. See EDC for registry studies for the registry model, and EDC for major depressive disorder trials for depression endpoints in a drug-trial setting. For psychedelic dosing-session designs with preparation and integration visits, see EDC for psychedelic clinical trials.

Capture is not an electronic health record and does not integrate with EHRs or clinic practice-management systems. A clinic using it for research enters study-specific data into the study, and the clinical record continues to live in the clinic's own system.

Published randomized ketamine trials in depression have often used an active placebo, such as midazolam, so that participants cannot easily tell from the sedation or other feelings which arm they are in. A well-known two-site trial in treatment-resistant depression randomized participants 2:1 to ketamine or midazolam and measured depression scores at 24 hours, with a primary clinician-rated scale. Whether a particular blind holds is a design question, and some designs assess it directly by asking participants and raters to guess the allocation. That guess is a data field. Build it as a typed question, completed by a blinded role, so the analysis can use it.

Observational clinic studies are different. They typically enroll consecutive patients starting a treatment series, collect baseline and repeated scale scores, and follow people after the series ends. There is no randomization and often no sham, but the same discipline applies: a fixed schedule with windows, defined instruments, defined safety fields and documented consent. The visit schedule can be built in the schedule of assessments builder, and window width tested with the visit window calculator.

Whichever the design, record the series structure: the session number within the series, the date, who attended, and whether the participant received concomitant medicines that affect interpretation. The concomitant medications template is a repeating table suited to that purpose. Treatment details such as product and dose are protocol data entered by staff exactly as recorded in the source; Capture does not suggest or check them clinically.

Prescribing information for the approved nasal esketamine product describes supervised administration in a certified setting with observation for at least two hours after each dose, including breathing checks, and blood pressure checks before and after dosing. Research protocols for other ketamine formulations set their own monitoring. The data-capture implication is that monitoring time points need to be explicit fields: when blood pressure was measured relative to the session, what it was, what action was taken if it crossed a protocol limit, and when discharge criteria were met. Build edit checks so a value above your alert limit cannot be saved without an action recorded. The clinical response itself happens outside Capture.

Ketamine is a controlled substance in many jurisdictions, and the rules for storage, prescribing, compounding and research supply vary by country and region. Capture does not replace your pharmacy or controlled-substance logs. What it supports in a study is generic accountability records: kits are dispensed under electronic signature, and an accountability report and CSV export are available in the same system as the EDC. Blinded roles see "Treatment assignment blinded". Reconcile with the pharmacy's own controlled-substance records according to your local rules.

Adverse events, including those of special interest in your protocol, follow the usual structure and the adverse event reporting workflow. Every change carries a field-level audit trail with timestamp, user, old value, new value and reason, which matters when a rater score is corrected or a vital sign entered late.