Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06365515
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-04-09
Brief Title:
Dopamine Reward Learning and Sex Hormones
Sponsor:
University Hospital Tuebingen
Organization:
University Hospital Tuebingen
Study Overview
Official Title:
Dopamine and Reward Learning Across Hormonal Transition Phases
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 ie 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
To this end dopamine intervention will be tested on effort-based decision-making and motivational circuits in three hormonal stages ie 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 eg 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 150mg375 mg L-DOPA benserazide and in another one a placebo pill will be administered Sex steroids eg progesterone estrogen testosterone and metabolic hormones eg 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
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 150mg375 mg L-DOPA benserazide and in another one a placebo pill will be administered Sex steroids eg progesterone estrogen testosterone and metabolic hormones eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None