The Pill Project - Oral Contraceptive and Serotonergic Brain Signaling
Status:
Recruiting
Trial end date:
2025-08-31
Target enrollment:
Participant gender:
Summary
Large register based work has shown that starting on oral contraceptives (OCs) is associated
with an increased risk of developing depressive episodes. It is not known why this is, but
changes in the serotonergic brain system might play a role. Intriguingly, in cross-sectional
work, the investigators have demonstrated a lower level of the serotonin 4 receptor globally
in the brain of healthy women using oral contraceptives compared to non-users. The order of
magnitude of this difference is comparable to what has been observed in depressed individuals
relative to healthy controls. In this study, the investigators will apply a longitudinal
design to determine if starting on oral contraceptives induces a reduction in the serotonin 4
receptor in healthy women and whether such changes are related to potential changes in
measures of cognition as well as mood/affect and sexual desire.
The study is a single-blind randomized placebo-controlled trial with a 3-month intervention
paradigm of either Femicept (2nd generation combined oral contraceptive) or placebo. The
investigators will include participants until 20 women have completed the study in each arm.
Participants will go through an investigational program, including PET and MR brain scans and
neuropsychological testing, before starting on the treatment and again during the third pill
cycle. To capture changes in mood/ and sexual desire, the participants will complete daily
questionnaires during the baseline menstrual cycle and during third pill cycle.
A linear latent variable model will be used to evaluate if OC use induces changes in the
serotonin 4 receptor level and such changes will be correlated to changes in secondary
outcomes (i.e., cognitive and psychometric measures).