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For researchers

Design, aims, and analytic approach.

NIMH R01MH1404722026–2031CLEAR-5
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Rationale

Suicide attempts among reproductive-age females peak perimenstrually, when the ovarian hormones are in their greatest flux. Across three crossover randomized trials in naturally cycling outpatients reporting suicidal ideation, perimenstrual estradiol stabilization prevented the acute symptom surge seen during baseline and placebo cycles.

Because patients differ in affective sensitivity to estradiol and progesterone, group-averaged analyses risk describing an average response that fits no individual patient. PINES is designed to recover person-level structure rather than average across it.

Design

1Baseline

Two cycles, densely sampled

Twice-daily symptom reporting with urinary hormone monitoring, across roughly two menstrual cycles.

2Crossover RCT

Estradiol vs. placebo

Perimenstrual estradiol against placebo, with resting-state fMRI in each condition.

3Follow-up

Six months

Follow-up contacts at two, four, and six months.

Aims

Analytic approach

Analyses use group iterative multiple model estimation (GIMME), which recovers shared and person-specific network structure within the same model rather than assuming it in advance. It is applied to behavioral time series in Aim 1 and to resting-state connectivity in Aim 2.

This page covers what is in the public award abstract. If you want to talk about methods in more detail, or about collaborating, please get in touch.

Under construction Trial registration, protocol, and data-sharing details will be posted here.

Team

Study team

Consultants