We enroll women in trials, but we still don’t track their hormones
STUDY: Lyndon S & Gonsalvez I, Br J Psychiatry 2026
STUDY TYPE: Guest editorial
FUNDING: Independent
Background
Mood, cognition, and sleep vary through the menstrual cycle, and are changed by pregnancy, perimenopause, and hormonal therapies. The authors in this editorial argue this “hormone blindness” adds noise to the research.
Psychiatry has gotten better at enrolling women in research, particularly after 1990 when the NIH stopped excluding women of child-bearing age from research. Despite better representation, only 5% of trials examined in 2022 analyzed sex as a variable, and few consider hormonal states.
Here are some implications. If the time-point for measuring outcomes falls in the two weeks before menses, premenstrual symptom flares may get mislabeled as treatment resistance. The lamotrigine studies did not account for a known birth control interaction (which lowers lamotrigine levels by 30-50%). Zolpidem’s belated dosing correction, after decades of underrecognized higher exposure in women, shows what unmeasured hormone state can cost in safety.
Menopausal hormone therapy (HRT) can ease sleep disruption and, depending on timing and formulation, some cognitive symptoms. There are numerous studies in general women, but only two small trials of HRT in clinical depression (and another four in schizophrenia).
The authors offer up several research methods to account for these hormonal variables. The variables they recommend documenting are also useful to track in practice:
- Reproductive stage at assessment (menstrual cycle phase,
pregnancy/postpartum interval, perimenopausal/menopausal status
or oestrous stage) - Exogenous hormone exposure (none, or type, dose and regimen, including hormonal contraception and hormone therapy)
Practice Implications
- Ask about menstrual patterns and hormonal therapies in every female patient.
- Learn more about how gender influences pharmacotherapy in our four-part Carlat podcast series.
—Chris Aiken, MD
Director, Psych Partners
Editor in Chief, Carlat Psychiatry Report
