Investigating the effects of dopamine and hormones on mood and motivation during the menstrual cycle
Dopamine and Reward Learning Across Hormonal Transition Phases
This study is testing how changes in hormones during the menstrual cycle affect mood and motivation in women and men, while also seeing if a dopamine supplement can make a difference.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 20 Years to 35 Years |
| Sex | All |
| Sponsor | University Hospital Tuebingen Academic / other |
| Locations | 1 site (Tübingen, BW) |
| Trial ID | NCT06365515 on ClinicalTrials.gov |
What this trial studies
This study examines how hormonal changes during the menstrual cycle influence dopamine transmission and its effects on motivation, mood, and energy homeostasis. It involves naturally cycling women and men who will undergo assessments of energy expenditure, hormonal levels, and decision-making tasks using functional magnetic resonance imaging (fMRI). Participants will receive either a dopamine precursor or a placebo in a double-blind design while their mood and premenstrual symptoms are tracked over a month. The goal is to understand the neuroendocrine mechanisms linking sex hormones and dopamine in relation to cognitive and emotional behaviors.
Who should consider this trial
Good fit: Ideal candidates are healthy, naturally cycling women aged 20-35 with regular menstrual cycles and men aged 20-35.
Not a fit: Patients with a history of mood disorders, severe medical problems, or those currently pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment of mood disorders related to hormonal fluctuations in women.
How similar studies have performed: While the specific approach of this study may be novel, previous studies have indicated a link between hormonal changes and mood disorders, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Naturally cycling healthy women and men * Age between 20-35 * Body-mass index (BMI): 18-28 kg/m2 * German or English language fluency * Normal or corrected to normal vision * For women: Regular menstrual cycle, no hormonal contraception (between 25 and 31 days) Exclusion Criteria: * Lifetime history of brain injury, stroke, epilepsy, seizures, schizophrenia, bipolar disorders, or severe alcohol/substance dependence, premenstrual dysphoric disorder (anamnestic survey) * Mood disorder, anxiety disorder, obsessive-compulsive disorder, trauma- and stressor related disorder, somatic symptom disorder or eating disorder in the last 12 months prior to testing (anamnestic survey) * Severe/uncontrolled medical problems such as hormonal, metabolic, heart or chronic diseases (e.g., severe hypertension, diabetes, dysfunctions of the thyroid, or congestive heart failure) * Pregnancy, delivery, and lactation (current and within the last year; anamnestic survey) * Undergoing regular hormonal treatment * Daily smoking (nicotine, shisha, e-cigarettes) or \>1/week (cannabis) * History of malignant melanoma, angle-closure glaucoma, gastrointestinal ulcers, and osteomalacia * Hypersensitivity to: Microcrystalline cellulose, Mannitol (Ph.Eur.), Calcium hydrogen phosphate, Pregelatinized Starch (Corn), Crospovidone, Ethylcellulose, Fumed silica, Docusate sodium, Magnesium Stearate (Ph.Eur.), Iron/Ferric oxide (E 172) * Taking certain types of medication (antihypertensive drugs, sympathomimetics, antipsychotics, drugs affecting the extrapyramidal motor system), non-selective MAO inhibitors or a combination of MAO-A and MAO-B inhibitors * Since we will only include healthy participants, other medications that might contraindicate Levodopa (e.g., for mental disorders) will be excluded as well. Any other occasional medication will be evaluated on a case-by-case basis. * Pathological hearing or increased sensitivity to loud noises * Contraindication for MRI * Claustrophobia * Non-removable metal objects on or in the body * Moderate or severe head injury
Where this trial is running
Tübingen, BW
- Department of Psychiatry & Psychotherapy, University of Tübingen — Tübingen, Bw, Germany (Recruiting)
Study contacts
- Principal investigator: Nils B Kroemer, Professor — Department of Psychiatry & Psychotherapy, university of Tübingen
- Study coordinator: Nils B Kroemer, Professor
- Email: nils.kroemer@uni-tuebingen.de
- Phone: +4922828711151
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.