Perimenopausal Effects of Estradiol on Anhedonia and Psychosis Study (PEEPs): study protocol for a neural and molecular mechanistic clinical trial Article Swipe
Melissa Walsh
,
Kathryn Gibson
,
Megan Hynd
,
Tory A. Eisenlohr‐Moul
,
Erin C. Walsh
,
Lauren Schiff
,
Fred Jarskog
,
David S. Lalush
,
Gabriel S. Dichter
,
Crystal Edler Schiller
·
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1186/s13063-023-07166-7
YOU?
·
· 2023
· Open Access
·
· DOI: https://doi.org/10.1186/s13063-023-07166-7
Background The perimenopausal transition is accompanied by psychiatric symptoms in over 10% of women. Symptoms commonly include depressed mood and anhedonia and less commonly include psychosis. Psychiatric symptoms have been linked to the depletion and/or variability of circulating estradiol, and estradiol treatment reduces perimenopausal anhedonia and psychosis in some women. Estrogen fluctuations may disrupt function in the mesolimbic reward system in some women, leading to psychiatric symptoms like anhedonia or psychosis. The Perimenopausal Effects of Estradiol on Anhedonia and Psychosis Study (PEEPs) is a mechanistic clinical trial that aims to (1) identify relationships between perimenopausal-onset anhedonia and psychosis and neuromolecular markers of mesolimbic reward responses and (2) determine the extent to which estradiol treatment-induced changes in mesolimbic reward responses are associated with alleviation of perimenopausal onset anhedonia or psychosis. Methods This study will recruit 100 unmedicated women ages 44–55 in the late-stage perimenopausal transition, sampling across the range of mild-to-high anhedonia and absent-to-moderate psychosis symptoms. Patients will be randomized to receive either estradiol or placebo treatment for 3 weeks. Clinical outcome measures will include symptoms of anhedonia (measured with Snaith–Hamilton Pleasure Scale; SHAPS) and psychosis (measured with Brief Psychiatric Rating Scale; BPRS psychosis subscale) as well as neural markers of mesolimbic reward system functioning, including reward-related fMRI activation and PET-derived measure of striatal dopamine binding. Pre-treatment associations between (1) SHAPS/BPRS scores and (2) reward-related striatal dopamine binding/BOLD activation will be examined. Furthermore, longitudinal mixed models will be used to estimate (1) symptom and neuromolecular trajectories as a function of estradiol vs. placebo treatment and (2) how changes in reward-related striatal dopamine binding and BOLD activation predict variability in symptom trajectories in response to estradiol treatment. Discussion This clinical trial will be the first to characterize neural and molecular mechanisms by which estradiol treatment ameliorates anhedonia and psychosis symptoms during the perimenopausal transition, thus laying the groundwork for future biomarker research to predict susceptibility and prognosis and develop targeted treatments for perimenopausal psychiatric symptoms. Furthermore, in alignment with the National Institute for Mental Health Research Domain Criteria initiative, this trial will improve our understanding of a range of disorders characterized by anhedonia, psychosis, and reward system dysfunction. Trial registration ClinicalTrials.gov NCT05282277
Related Topics
Concepts
Anhedonia
Psychosis
Scale for the Assessment of Negative Symptoms
Brief Psychiatric Rating Scale
Medicine
Mood
Psychiatry
Psychology
Schizophrenia (object-oriented programming)
Clinical psychology
Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1186/s13063-023-07166-7
- https://trialsjournal.biomedcentral.com/counter/pdf/10.1186/s13063-023-07166-7
- OA Status
- gold
- Cited By
- 5
- References
- 64
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4322627117
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4322627117Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1186/s13063-023-07166-7Digital Object Identifier
- Title
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Perimenopausal Effects of Estradiol on Anhedonia and Psychosis Study (PEEPs): study protocol for a neural and molecular mechanistic clinical trialWork title
- Type
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articleOpenAlex work type
- Language
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enPrimary language
- Publication year
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2023Year of publication
- Publication date
-
2023-02-28Full publication date if available
- Authors
-
Melissa Walsh, Kathryn Gibson, Megan Hynd, Tory A. Eisenlohr‐Moul, Erin C. Walsh, Lauren Schiff, Fred Jarskog, David S. Lalush, Gabriel S. Dichter, Crystal Edler SchillerList of authors in order
- Landing page
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https://doi.org/10.1186/s13063-023-07166-7Publisher landing page
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https://trialsjournal.biomedcentral.com/counter/pdf/10.1186/s13063-023-07166-7Direct link to full text PDF
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YesWhether a free full text is available
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goldOpen access status per OpenAlex
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https://trialsjournal.biomedcentral.com/counter/pdf/10.1186/s13063-023-07166-7Direct OA link when available
- Concepts
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Anhedonia, Psychosis, Scale for the Assessment of Negative Symptoms, Brief Psychiatric Rating Scale, Medicine, Mood, Psychiatry, Psychology, Schizophrenia (object-oriented programming), Clinical psychologyTop concepts (fields/topics) attached by OpenAlex
- Cited by
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5Total citation count in OpenAlex
- Citations by year (recent)
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2025: 2, 2024: 2, 2023: 1Per-year citation counts (last 5 years)
- References (count)
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64Number of works referenced by this work
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10Other works algorithmically related by OpenAlex
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| abstract_inverted_index.initiative, | 337 |
| abstract_inverted_index.mechanistic | 85 |
| abstract_inverted_index.psychiatric | 8, 66, 322 |
| abstract_inverted_index.transition, | 144, 302 |
| abstract_inverted_index.unmedicated | 136 |
| abstract_inverted_index.variability | 36, 267 |
| abstract_inverted_index.Furthermore, | 232, 324 |
| abstract_inverted_index.associations | 217 |
| abstract_inverted_index.binding/BOLD | 227 |
| abstract_inverted_index.characterize | 285 |
| abstract_inverted_index.dysfunction. | 356 |
| abstract_inverted_index.fluctuations | 52 |
| abstract_inverted_index.functioning, | 204 |
| abstract_inverted_index.longitudinal | 233 |
| abstract_inverted_index.mild-to-high | 150 |
| abstract_inverted_index.registration | 358 |
| abstract_inverted_index.trajectories | 245, 270 |
| abstract_inverted_index.Pre-treatment | 216 |
| abstract_inverted_index.characterized | 349 |
| abstract_inverted_index.relationships | 93 |
| abstract_inverted_index.understanding | 343 |
| abstract_inverted_index.Perimenopausal | 73 |
| abstract_inverted_index.neuromolecular | 100, 244 |
| abstract_inverted_index.perimenopausal | 3, 44, 125, 143, 301, 321 |
| abstract_inverted_index.reward-related | 206, 224, 259 |
| abstract_inverted_index.susceptibility | 313 |
| abstract_inverted_index.Snaith–Hamilton | 180 |
| abstract_inverted_index.treatment-induced | 114 |
| abstract_inverted_index.ClinicalTrials.gov | 359 |
| abstract_inverted_index.absent-to-moderate | 153 |
| abstract_inverted_index.perimenopausal-onset | 95 |
| cited_by_percentile_year.max | 97 |
| cited_by_percentile_year.min | 89 |
| corresponding_author_ids | https://openalex.org/A5029843102 |
| countries_distinct_count | 1 |
| institutions_distinct_count | 10 |
| corresponding_institution_ids | https://openalex.org/I114027177 |
| sustainable_development_goals[0].id | https://metadata.un.org/sdg/3 |
| sustainable_development_goals[0].score | 0.8199999928474426 |
| sustainable_development_goals[0].display_name | Good health and well-being |
| citation_normalized_percentile.value | 0.79554029 |
| citation_normalized_percentile.is_in_top_1_percent | False |
| citation_normalized_percentile.is_in_top_10_percent | False |