Hormonal ChangesNCT06365515
Dopamine, Reward Learning and Sex Hormones
A study testing Levodopa administration in people with Hormonal Changes and Menstrual Cycle, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Hormonal transition periods during the menstrual cycle may predispose women to mental disorders. Hormonal fluctuations provide specific neuroendocrine conditions that modulate brain structure and function and these actions affect cognitive and emotional behaviors and affect energy and mood homeostasis. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Hormonal Changes, Menstrual Cycle
- What is being tested?
- Levodopa administration
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- May 2024to Dec 2025
- Phase
- Interventional
- 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 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Johannes Klaus, MD contact
Germany1 site, 1 recruiting
- Recruiting
Department of Psychiatry & Psychotherapy, University of Tübingen
Tübingen, Baden-Wurttemberg, 72076
Andrea Heberle, Andrea.Heberle@med.uni-tuebingen.de
About this study
Official title: Dopamine and Reward Learning Across Hormonal Transition Phases
Hormonal transition periods during the menstrual cycle may predispose women to mental disorders. Hormonal fluctuations provide specific neuroendocrine conditions that modulate brain structure and function and these actions affect cognitive and emotional behaviors and affect energy and mood homeostasis. It is thought that these changes are driven by altered dopamine transmission. Here, the investigators aim to examine (1) how sex hormones and dopamine are linked and also (2) how hormonal changes affect motivation, mood, and energy homeostasis.
To this end, dopamine intervention will be tested on effort-based decision-making and motivational circuits in three hormonal stages (i.e., women in early-follicular phase (EF), women in mid-luteal phase (ML), and men). Additionally, the effects of hormonal status on metabolic indices will be tested, and its effects on mood fluctuations in a period of a month.
The investigator hypothesizes that women in EF cycle phase (1) have naturally less dopamine and show less effort, and (2) they show greater improvement in effort-based decision-making after Levodopa administration. The investigator has exploratory outcomes about (3) sex differences in reward-learning with and without Levodopa administration and explores if these differences correlate with elevated female sex hormone levels. Moreover, it is hypothesized that (4) hormonal fluctuations affect energy homeostasis, thus women in their EF cycle phase have higher energy expenditure and (5) they report more negative mood than in their mid-luteal (ML) cycle phase.
Read the detailed description
This study will investigate naturally cycling women (n = 60) and men (n = 30). During the intake session (C1) energy expenditure of men and women in their EF cycle phase will be assessed by indirect calorimetry, participants will perform a training EAT task, and hormones (e.g., estradiol, progesterone, testosterone, and their precursor steroids and metabolites) will be assessed from blood samples. Energy expenditure will be assessed at another time point again (C2) (women with different hormonal profiles) and blood samples will be collected.
During the neuroimaging sessions (S1, S2) both men and women will be measured, 30 women in their EF menstrual cycle phase and another 30 women in their ML phase. All participants will take part in the Effort Allocation Task, an effort-based decision-making task during an L-DOPA-based pharmaco-neuroimaging using functional magnetic resonance imaging (fMRI). To disentangle the influence of L-DOPA within a randomized double-blind design, in one session an L-DOPA-based pill (Madopar, 150mg/37.5 mg L-DOPA/ benserazide) and in another one a placebo pill will be administered. Sex steroids (e.g., progesterone, estrogen, testosterone) and metabolic hormones (e.g., glucose, insulin, triglyceride, ghrelin) will be obtained from blood samples. Before and after the MR scanning a reinforcement learning task will be examined.
Over one month, a smartphone survey will be used to regularly record mood, premenstrual symptoms, and information on food cravings. Participants will be asked to start filling out the daily survey after C1 and continue it for 30 days.
- Conditions
- Hormonal Changes, Menstrual Cycle
- Being tested
- Levodopa administration, Placebo administration
- Keywords
- dopamine, fMRI, energy homeostasis, mood homeostasis, sex hormones, motivation, menstrual cycle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levodopa administrationDrug
Also called Madopar® tablets (Levodopa and Berazidhydrochlorid; Roche)
To boost dopamine levels 150mg/37.5 mg L-DOPA/benserazide will be administered in line with recent studies (Kroemer et al., 2019). Maximum plasma concentration of Madopar occur ~60 minutes after drug administration. Participants will start the Effort Allocation Task 45 minutes after Levodopa administration.
Placebo administrationDrug
Also called Placebo tablets (P-Tabletten White, Lichtenstein)
Placebo tablets will be administered as the placebo-controlled condition.
| Study group | Role | What they receive |
|---|---|---|
| Women in EF | Experimental | Healthy women in the early follicular menstrual cycle phase Receives: Drug: Levodopa administration; Drug: Placebo administration |
| Women in ML | Experimental | Healthy women in the mid-luteal menstrual cycle phase Receives: Drug: Levodopa administration; Drug: Placebo administration |
| Men | Experimental | Healthy men Receives: Drug: Levodopa administration; Drug: Placebo administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motivation to work for rewards: force of pressing grip force device (GFD) to gain food and monetary rewards circuitry during effort-based decision-making
Operationalized via the relative force exerted on GFD in an effort allocation task during either the first seconds of each trial (invigoration) or each complete trial (maintenance). Levodopa compared to placebo condition. Outcomes will be compared between groups and will be associated with blood hormone levels.
Measured: During Effort Allocation Task (30 minutes) 45-75 minutes after pharmacological challenge
Reward-related brain responses in the reward network during effort-based decision-making
Comparing brain activity (BOLD signals) in response to feedback in regions of the reward network (ROIs: Nucleus Accumbens (NAcc), Putamen, Caudate, Ventral Tegmental Area (VTA), Amygdala, Prefrontal Cortex (PFC), Orbitofrontal cortex (OFC), Anterior Cingulate Cortex (ACC), Insula). Levodopa compared to placebo condition. Outcomes will be compared between groups and will be associated with blood hormone levels.
Measured: During task-based neuroimaging (45-75 minutes after drug administration)
Reward anticipation on a neural level
Comparing brain activity (BOLD signals) in reward-related brain regions (ROIs: NAcc, striatum, PFC, ACC) during the presentation of reward cues with high vs. low reward magnitude after Levodopa administration vs. placebo. Outcomes will be compared between groups and will be associated with blood hormone levels.
Measured: During task-based neuroimaging (45-75 minutes after drug administration)
Execution of effort on a neural level
Comparing brain activity (BOLD signals) in reward-related brain regions (ROIs: Striatum, Insula, ACC, PFC) during force exerted on GFD in an effort allocation task after Levodopa administration vs. placebo. Outcomes will be compared between groups and will be associated with blood hormone levels.
Measured: During task-based neuroimaging (45-75 minutes after drug administration)
Secondary outcomes (5)
Resting-state functional connectivity
Resting-state functional connectivity of regions of the mesocorticolimbic circuitry (ROIs: Nucleus Accumbens, Putamen, Caudata, Ventral Tegmental Area, Amygdala, ventral medial Prefrontal Cortex, Orbitofrontal cortex, Anterior Cingulate Cortex) after Levodopa administration vs. placebo.
Measured: During resting-state neuroimaging (10 minutes)
Changes in reinforcement learning
Changes in reward-learning parameters, which are based on choices in the task before Levodopa administration vs. after Levodopa administration and compared to placebo condition.
Measured: During value-based decision-making task (15 minutes) measured 15 minutes before Levodopa administration and 90 min after
Menstrual cycle induced changes in mood and food cravings
Changes in positive and negative mood ratings (5 mood and 5 stress items, scale 1-10) and in premenstrual symptoms (PSST items, Likert scale 1-4), and in food-craving (FCQ-S items, Likert scale 1-5) measured with ecological momentary assessment.
Measured: Measured every day (5 minutes) over the period of one month
Changes in resting energy expenditure
Menstrual cycle-related changes in resting energy expenditure, measured with indirect calorimetry. Resting energy expenditure will be measured during the early follicular phase and then around ovulation
Measured: Measured twice 1-2 weeks apart, measurement takes 30 minutes
Changes in metabolic hormone levels during the menstrual cycle
Changes in metabolic hormone levels (insulin, glucose, ghrelin, leptin; μg/dL or nmol/L) will be assessed from blood samples during the early follicular phase, ovulatory phase, and mid-luteal phase.
Measured: Measured 4 times (5 minutes/day) during a period of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study startMay 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormonal ChangesStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The investigators will assess the effects of Levodopa administration on reward-learning using a double-blind randomized cross-over design. In a within-subject design, participants will get both conditions (Levodopa/placebo) at different time points (a few days apart). After drug/placebo administration we will assess cerebral blood flow and functional connectivity at rest (via functional MR imaging) during effort-based decision making task.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation, Uppsala University
- Responsible party
- Sponsor
- Investigators
- Nils B Kroemer, Professor, Principal investigator, Department of Psychiatry & Psychotherapy, university of Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365515
- Sponsor's protocol ID
- TUE010_IRTG_P5
- Status last verified
- Aug 2023
- First submitted
- 9 Apr 2024
- Last updated
- 9 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the publication of the key results of the study, all anonymized imaging data will be made publicly available (e.g., at openfmri.org)
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dopamine and Reward Learning Across Hormonal Transition Phases
- ClinicalTrials.gov ID
- NCT06365515
- Acronym / sponsor ID
- TUE010_IRTG_P5
- Conditions
- Hormonal Changes, Menstrual Cycle
- Keywords
- dopamine, fMRI, energy homeostasis, mood homeostasis, sex hormones, motivation, menstrual cycle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- German Research Foundation, Uppsala University
- Study start
- May 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 15 Apr 2024 (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.
Hormonal transition periods during the menstrual cycle may predispose women to mental disorders. Hormonal fluctuations provide specific neuroendocrine conditions that modulate brain structure and function and these actions affect cognitive and emotional behaviors and affect energy and mood homeostasis. It is thought that these changes are driven by altered dopamine transmission. Here, the investigators aim to examine (1) how sex hormones and dopamine are linked and also (2) how hormonal changes affect motivation, mood, and energy homeostasis.
To this end, dopamine intervention will be tested on effort-based decision-making and motivational circuits in three hormonal stages (i.e., women in early-follicular phase (EF), women in mid-luteal phase (ML), and men). Additionally, the effects of hormonal status on metabolic indices will be tested, and its effects on mood fluctuations in a period of a month.
The investigator hypothesizes that women in EF cycle phase (1) have naturally less dopamine and show less effort, and (2) they show greater improvement in effort-based decision-making after Levodopa administration. The investigator has exploratory outcomes about (3) sex differences in reward-learning with and without Levodopa administration and explores if these differences correlate with elevated female sex hormone levels. Moreover, it is hypothesized that (4) hormonal fluctuations affect energy homeostasis, thus women in their EF cycle phase have higher energy expenditure and (5) they report more negative mood than in their mid-luteal (ML) cycle phase.
Detailed description
This study will investigate naturally cycling women (n = 60) and men (n = 30). During the intake session (C1) energy expenditure of men and women in their EF cycle phase will be assessed by indirect calorimetry, participants will perform a training EAT task, and hormones (e.g., estradiol, progesterone, testosterone, and their precursor steroids and metabolites) will be assessed from blood samples. Energy expenditure will be assessed at another time point again (C2) (women with different hormonal profiles) and blood samples will be collected.
During the neuroimaging sessions (S1, S2) both men and women will be measured, 30 women in their EF menstrual cycle phase and another 30 women in their ML phase. All participants will take part in the Effort Allocation Task, an effort-based decision-making task during an L-DOPA-based pharmaco-neuroimaging using functional magnetic resonance imaging (fMRI). To disentangle the influence of L-DOPA within a randomized double-blind design, in one session an L-DOPA-based pill (Madopar, 150mg/37.5 mg L-DOPA/ benserazide) and in another one a placebo pill will be administered. Sex steroids (e.g., progesterone, estrogen, testosterone) and metabolic hormones (e.g., glucose, insulin, triglyceride, ghrelin) will be obtained from blood samples. Before and after the MR scanning a reinforcement learning task will be examined.
Over one month, a smartphone survey will be used to regularly record mood, premenstrual symptoms, and information on food cravings. Participants will be asked to start filling out the daily survey after C1 and continue it for 30 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The investigators will assess the effects of Levodopa administration on reward-learning using a double-blind randomized cross-over design. In a within-subject design, participants will get both conditions (Levodopa/placebo) at different time points (a few days apart). After drug/placebo administration we will assess cerebral blood flow and functional connectivity at rest (via functional MR imaging) during effort-based decision making task.
| Arm | Type | Receives |
|---|---|---|
| Women in EF | Experimental | Drug: Levodopa administration, Drug: Placebo administrationHealthy women in the early follicular menstrual cycle phase |
| Women in ML | Experimental | Drug: Levodopa administration, Drug: Placebo administrationHealthy women in the mid-luteal menstrual cycle phase |
| Men | Experimental | Drug: Levodopa administration, Drug: Placebo administrationHealthy men |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levodopa administrationAlso: Madopar® tablets (Levodopa and Berazidhydrochlorid; Roche)To boost dopamine levels 150mg/37.5 mg L-DOPA/benserazide will be administered in line with recent studies (Kroemer et al., 2019). Maximum plasma concentration of Madopar occur ~60 minutes after drug administration. Participants will start the Effort Allocation Task 45 minutes after Levodopa administration. | Drug | Men, Women in EF, Women in ML |
| Placebo administrationAlso: Placebo tablets (P-Tabletten White, Lichtenstein)Placebo tablets will be administered as the placebo-controlled condition. | Drug | Men, Women in EF, Women in ML |
Primary outcome
Motivation to work for rewards: force of pressing grip force device (GFD) to gain food and monetary rewards circuitry during effort-based decision-making
Time frame: During Effort Allocation Task (30 minutes) 45-75 minutes after pharmacological challenge
Operationalized via the relative force exerted on GFD in an effort allocation task during either the first seconds of each trial (invigoration) or each complete trial (maintenance). Levodopa compared to placebo condition. Outcomes will be compared between groups and will be associated with blood hormone levels.
Reward-related brain responses in the reward network during effort-based decision-making
Time frame: During task-based neuroimaging (45-75 minutes after drug administration)
Comparing brain activity (BOLD signals) in response to feedback in regions of the reward network (ROIs: Nucleus Accumbens (NAcc), Putamen, Caudate, Ventral Tegmental Area (VTA), Amygdala, Prefrontal Cortex (PFC), Orbitofrontal cortex (OFC), Anterior Cingulate Cortex (ACC), Insula). Levodopa compared to placebo condition. Outcomes will be compared between groups and will be associated with blood hormone levels.
Reward anticipation on a neural level
Time frame: During task-based neuroimaging (45-75 minutes after drug administration)
Comparing brain activity (BOLD signals) in reward-related brain regions (ROIs: NAcc, striatum, PFC, ACC) during the presentation of reward cues with high vs. low reward magnitude after Levodopa administration vs. placebo. Outcomes will be compared between groups and will be associated with blood hormone levels.
Execution of effort on a neural level
Time frame: During task-based neuroimaging (45-75 minutes after drug administration)
Comparing brain activity (BOLD signals) in reward-related brain regions (ROIs: Striatum, Insula, ACC, PFC) during force exerted on GFD in an effort allocation task after Levodopa administration vs. placebo. Outcomes will be compared between groups and will be associated with blood hormone levels.
5 secondary outcomes
Resting-state functional connectivity
Time frame: During resting-state neuroimaging (10 minutes)
Changes in reinforcement learning
Time frame: During value-based decision-making task (15 minutes) measured 15 minutes before Levodopa administration and 90 min after
Menstrual cycle induced changes in mood and food cravings
Time frame: Measured every day (5 minutes) over the period of one month
Changes in resting energy expenditure
Time frame: Measured twice 1-2 weeks apart, measurement takes 30 minutes
Changes in metabolic hormone levels during the menstrual cycle
Time frame: Measured 4 times (5 minutes/day) during a period of 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: Yes. After the publication of the key results of the study, all anonymized imaging data will be made publicly available (e.g., at openfmri.org)
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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.
Johannes Klaus, MD contact
Nils B Kroemer, Professor principal investigator
Department of Psychiatry & Psychotherapy, university of Tübingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Levodopa administration in people with Hormonal Changes and Menstrual Cycle, run by University Hospital Tuebingen 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 6 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 9 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nils B Kroemer, Professor (+4922828711151, nils.kroemer@uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motivation to work for rewards: force of pressing grip force device (GFD) to gain food and monetary rewards circuitry during effort-based decision-making (time frame: During Effort Allocation Task (30 minutes) 45-75 minutes after pharmacological challenge). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2024.