NCT07802158
Discontinuing Psychotropic Medication Before Psychotherapy for PTSD
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Record History
All 1 version: 1 with changes below.
- Study First Submitted
Endpoints
Primary
Secondary (3)
Arms and interventions
Patients treated from September 2026 who are using amitriptyline, mirtazapine, quetiapine, topiramate, zolpidem, and/or zopiclone off-label for PTSD-related symptoms and for whom tapering and discontinuation before trauma-focused psychotherapy is initiated under the revised medication-review policy. Cohort classification is based on initiation of the discontinuation strategy rather than successful completion of tapering. Primary analyses compare patients with historical users of the same specific medication.
Historical patients treated in 2021-2024 who were using one or more of the same target medications at the start of trauma-focused psychotherapy. Under the clinical policy in place during this period, these medications were generally continued during psychotherapy. For the primary analyses, patients will be compared with 2026 patients using the same specific target medication.
Patients treated in 2026 who are using psychotropic medication but none of the six target medications and are therefore not subject to the target-medication discontinuation policy. This cohort is used to estimate secular changes in psychotherapy outcomes and as the active comparator in difference-in-differences analyses.
Historical patients treated in 2021-2024 who were using psychotropic medication but none of the six target medications. These patients provide the historical counterpart to the 2026 non-target psychotropic comparator. The two cohorts will be propensity-score matched, including on psychotropic medication use and relevant baseline clinical characteristics.