NCT04086316: DepCy

Depressive Symptoms and Subjective Stress in the Course of the Menstrual Cycle - an Ambulatory Assessment Study.

Completed Last updated 17 February 2023

What this trial tests

trial in Major Depressive Episode in 77 participants. Completed in 30 December 2022.

Timeline

15 January 2020

Primary endpoint
15 April 2021

30 December 2022

Quick facts

Lead sponsor	Freie Universität Berlin
Status	Completed
Study type	OBSERVATIONAL
Enrollment	77
Start date	15 January 2020
Primary completion	15 April 2021
Estimated completion	30 December 2022
Sites	1 location across Germany

Conditions studied

• Major Depressive Episode — all drugs for Major Depressive Episode →

Sponsor

Freie Universität Berlin

Who can join

Adults 18 to 45, female only, with Major Depressive Episode. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

Major changes in female sex hormone concentrations influence the development of depressive symptoms in women. This hypothesis has been thoroughly investigated with regard to the menopause, the postpartal phase and also premenstrual dysphoric disorder. However, much less is known regarding the impact of female sex hormone fluctuations on depression during the regular menstrual cycle. There are indications that during the luteal phase, women might be more vulnerable to the development of depressive symptoms, while during the follicular phase and at ovulation, hormone concentrations might present a protective factor against depressive symptomatology. Subjective stress could mediate the relationship between depressive symptom development and the menstrual cycle phases. The complex interaction between sex hormones and psychological symptoms in the course of menstrual cycle phases is still understudied.

Method:

74 women (37 with and 37 without current depressive episode), will take part in a smartphone-based ambulatory assessment. Women will provide daily ratings of depressive symptoms and perceived stress for a period of one menstrual cycle (approx. 26-30 days). Three menstrual cycle phases will be assessed - the follicular phase, ovulation and the luteal phase. An ambulatory assessment will be used for these daily assessments. To assess the menstrual cycle phase participants will use ovulation tests on five days in the late follicular phase.

The following research questions will be investigated:

Research question 1: Do depressive symptoms (number and severity) change in the course of the menstrual cycle within the two groups? Research question 2: Which depressive symptoms are particularly sensitive to changes in the course of the menstrual cycle phases? Research question 3: Does the subjective stress change in the course of the menstrual cycle within the two groups? Research question 4: Are there differences between depressive and healthy women in terms of changes in depressive symptoms and subjective stress experience?

Implications:

The aim of the study is to investigate women-specific psychobiological factors influencing depression. Therefore, fluctuations in depressive symptoms and subjective stress experience will be investigated as a function of the respective menstrual cycle phases. The identification of cycle phases associated with increased or reduced vulnerability to depressive symptoms will support the development of women-specific prevention and treatment programs.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Higher Depressive Symptoms in Irregular Menstrual Cycles: Converging Evidence from Cross-Sectional and Prospective Assessments.
   Klusmann H, Kapp C, Engel S, Schumacher T, et al · · 2024 · cited 4× · PMID 38194941 · DOI 10.1159/000535565
2. Menstrual cycle related depressive symptoms and their diurnal fluctuations - an ambulatory assessment study.
   Klusmann H, Brose A, Schulze L, Engel S, et al · · 2024 · PMID 39551735 · DOI 10.1186/s12905-024-03438-9