Major Depressive EpisodeDepCyNCT04086316
Depressive Symptoms and Subjective Stress in the Course of the Menstrual Cycle - an Ambulatory Assessment Study.
An observational study of Major Depressive Episode, run by Freie Universität Berlin at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Episode
- How many people
- 77 participants
- Where
- 1 siteGermany
- Study dates
- 15 Jan 2020to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Sample will be recruited all over Germany.
Who may be able to join
- female sex
- current diagnosis of a major depression episode
- minimum age of 18 years
- regular menstrual cycle.
- female sex;
- minimum age of 18 years;
- regular menstrual cycle.
Who cannot join
- Pregnancy less than one year ago;
- women who are breastfeeding;
- bipolar disorder;
- acute suicidal tendencies;
- schizophrenic disorders (F20-29);
- substance use disorders
Show all 14Show fewer
- psychotropic drugs in the last six months;
- chronic somatic diseases.
- For participants without major depressive episode:
- current or lifetime mental disorder;
- pregnancy less than one year ago;
- women who are breastfeeding;
- psychotropic drugs in the last six months;
- chronic somatic diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vulnerable and Resilient Phases During the Menstrual Cycle and Their Influence on Depressive Symptoms and Stress. An Ambulatory Assessment Study on Healthy Women and Women With Depression.
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.
Read more
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.
- Conditions
- Major Depressive Episode
- Keywords
- Menstrual Cycle, Major Depressive Disorder, Stress, Sex hormones, Depression, Female, Ambulatory Assessment
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Depression Group | Naturally cycling women with a major depressive episode, assessed by Structured Clinical Interview for DSM-5 (SCID Clinical Version) | |
| Healthy Group | Naturally cycling women without a major depressive episode, assessed by Structured Clinical Interview for DSM-5 (SCID Clinical Version) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Depressive Symptoms between the menstrual cycle phases
Depressive Symptoms will be measured with the Patient Health Questionnaire (PHQ-9), which will be adapted for the ambulatory assessment use (e.g. changing "in the last two weeks" to "right now").
Measured: Depressive Symptoms will be assessed daily with an ambulatory assessment for the duration of one menstrual cycle (approx. 28 days).
Changes in subjective stress (self report) between the menstrual cycle phases
Stress Symptoms will be measured with the short Version of the Perceived Stress Scale (PSS-4), which will be adapted for the ambulatory assessment use (e.g. changing "in the last two weeks" to "right now").
Measured: Subjective stress will be assessed daily with an ambulatory assessment for the duration of one menstrual cycle (approx. 28 days).
Secondary outcomes (2)
Differences between women with and without a Major depressive Episode
Differences between women with and without a Major depressive Episode (measured with the SCID-CV)
Measured: Depressive Symptoms will be assessed daily with an ambulatory assessment for the duration of one menstrual cycle (approx. 28 days).
Differences between women with and without a Major depressive Episode
Differences between women with and without a Major depressive Episode (measured with the SCID-CV)
Measured: Subjective stress will be assessed daily with an ambulatory assessment for the duration of one menstrual cycle (approx. 28 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2019
- Study start15 Jan 2020
- Primary completion15 Apr 2021
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive EpisodeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Freie Universität Berlin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sarah Schumacher, Freie Universität Berlin
- Investigators
- Sarah Schumacher, PhD, Principal investigator, Freie Universität Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04086316
- Sponsor's protocol ID
- CycleDepression
- Acronym
- DepCy
- Status last verified
- Feb 2023
- First submitted
- 27 Aug 2019
- Last updated
- 17 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Klusmann H, Brose A, Schulze L, Engel S, Laufer S, Bucklein E, Knaevelsrud C, Schumacher S. Menstrual cycle related depressive symptoms and their diurnal fluctuations - an ambulatory assessment study. BMC Womens Health. 2024 Nov 18;24(1):611. doi: 10.1186/s12905-024-03438-9.
PubMed 39551735
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vulnerable and Resilient Phases During the Menstrual Cycle and Their Influence on Depressive Symptoms and Stress. An Ambulatory Assessment Study on Healthy Women and Women With Depression.
- ClinicalTrials.gov ID
- NCT04086316
- Acronym / sponsor ID
- DepCy / CycleDepression
- Conditions
- Major Depressive Episode
- Keywords
- Menstrual Cycle, Major Depressive Disorder, Stress, Sex hormones, Depression, Female, Ambulatory Assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Freie Universität BerlinUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 11 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Depression Group | – | –Naturally cycling women with a major depressive episode, assessed by Structured Clinical Interview for DSM-5 (SCID Clinical Version) |
| Healthy Group | – | –Naturally cycling women without a major depressive episode, assessed by Structured Clinical Interview for DSM-5 (SCID Clinical Version) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Sample will be recruited all over Germany.
Key inclusion criteria (7 listed)
- female sex
- current diagnosis of a major depression episode
- minimum age of 18 years
- regular menstrual cycle.
- female sex;
Key exclusion criteria (14 listed)
- Pregnancy less than one year ago;
- women who are breastfeeding;
- bipolar disorder;
- acute suicidal tendencies;
- schizophrenic disorders (F20-29);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in Depressive Symptoms between the menstrual cycle phases
Time frame: Depressive Symptoms will be assessed daily with an ambulatory assessment for the duration of one menstrual cycle (approx. 28 days).
Depressive Symptoms will be measured with the Patient Health Questionnaire (PHQ-9), which will be adapted for the ambulatory assessment use (e.g. changing "in the last two weeks" to "right now").
Changes in subjective stress (self report) between the menstrual cycle phases
Time frame: Subjective stress will be assessed daily with an ambulatory assessment for the duration of one menstrual cycle (approx. 28 days).
Stress Symptoms will be measured with the short Version of the Perceived Stress Scale (PSS-4), which will be adapted for the ambulatory assessment use (e.g. changing "in the last two weeks" to "right now").
2 secondary outcomes
Differences between women with and without a Major depressive Episode
Time frame: Depressive Symptoms will be assessed daily with an ambulatory assessment for the duration of one menstrual cycle (approx. 28 days).
Differences between women with and without a Major depressive Episode
Time frame: Subjective stress will be assessed daily with an ambulatory assessment for the duration of one menstrual cycle (approx. 28 days).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2023.
- Derived from this study: PubMed 39551735Klusmann H, Brose A, Schulze L, Engel S, Laufer S, Bucklein E, Knaevelsrud C, Schumacher S. Menstrual cycle related depressive symptoms and their diurnal fluctuations - an ambulatory assessment study. BMC Womens Health. 2024 Nov 18;24(1):611. doi: 10.1186/s12905-024-03438-9.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Schumacher, PhD principal investigator
Freie Universität Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Episode, run by Freie Universität Berlin at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Depressive Symptoms between the menstrual cycle phases (time frame: Depressive Symptoms will be assessed daily with an ambulatory assessment for the duration of one menstrual cycle (approx. 28 days).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04086316, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2023.