Trial · NCT01208324
Estrogen and Serotonin on Changing Brain Chemistry
NCT01208324, Not applicable, Completed, University of Colorado, Denver; results first posted 2021-04-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Estrogen and Serotonin on Changing Brain Chemistry. Trials, record NCT01208324. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01208324
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Estrogen and Serotonin on Changing Brain Chemistry
- NCT number
- NCT01208324
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 47 participants, actual
- Lead sponsor
- University of Colorado, Denver
- Conditions
- Menopause
- Interventions
- estrogen patch, Amino acids, Placebo Patch, Placebo pills
- First posted
- 2010-09-23
- Last updated
- 2021-04-02
- Results first posted
- 2021-04-02
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change in BOLD Signal | 8 weeks | To replicate and extend our previous behavioral findings of an interaction between estrogen therapy (ET) and tryptophan depletion on verbal memory in a group of early menopausal women randomized to receive ET. Blood-oxygen-level dependent or BOLD signal is the outcome of BOLD imaging, which is a technique used in functional MRI. BOLD signal reflects changes in regional cerebral blood flow which delineate regional activity. A positive BOLD signal marks an increase in regional blood flow, while a negative BOLD signal marks a decrease in regional blood flow. A positive percent change means that between scans the BOLD signal i.e. blood flow in that region has increased, a negative percent change means that the BOLD signal has decreased between scans. |
| Secondary | Evaluate the Changes in Verbal Working Memory Mediated Through the Dorsolateral Prefrontal Cortex. | 8 weeks | To evaluate the extent to which effects of ET (estrogen therapy) and TRP-D on verbal working memory are mediated through the dorsolateral prefrontal cortex. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change in BOLD Signal | 8 weeks | percentage of BOLD signal changes | MEAN | |
| SECONDARY | Evaluate the Changes in Verbal Working Memory Mediated Through the Dorsolateral Prefrontal Cortex. | 8 weeks | This outcome measure was not assessed. No participants were analyzed and no data was collected. |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change in BOLD Signal | High Ace | -.43 | 95% Confidence Interval -.65 to -.22 | percentage of BOLD signal changes | |
| Percent Change in BOLD Signal | Low Ace | .20 | 95% Confidence Interval -.16 to .21 | percentage of BOLD signal changes |
Source ClinicalTrials.gov
Participant flow40
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Pre-randomization of Patch | STARTED | Active Patch: Active Tryptophan, Then Sham Tryptophan | 14 | |
| Pre-randomization of Patch | STARTED | Active Patch: Sham Tryptophan, Then Active Tryptophan | 15 | |
| Pre-randomization of Patch | STARTED | Sham Patch: Active Tryptophan, Then Sham Tryptophan | 10 | |
| Pre-randomization of Patch | STARTED | Sham Patch: Sham Tryptophan, Then Active Tryptophan | 8 | |
| Pre-randomization of Patch | Test Day 1 | Active Patch: Active Tryptophan, Then Sham Tryptophan | 14 | |
| Pre-randomization of Patch | Test Day 1 | Active Patch: Sham Tryptophan, Then Active Tryptophan | 15 | |
| Pre-randomization of Patch | Test Day 1 | Sham Patch: Active Tryptophan, Then Sham Tryptophan | 10 | |
| Pre-randomization of Patch | Test Day 1 | Sham Patch: Sham Tryptophan, Then Active Tryptophan | 8 | |
| Pre-randomization of Patch | Test Day 2 | Active Patch: Active Tryptophan, Then Sham Tryptophan | 14 | |
| Pre-randomization of Patch | Test Day 2 | Active Patch: Sham Tryptophan, Then Active Tryptophan | 15 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Active Patch: Active Tryptophan, Then Sham Tryptophan | 0 | 15 |
| Total, all-cause mortality | Active Patch: Sham Tryptophan, Then Active Tryptophan | 0 | 14 |
| Total, all-cause mortality | Sham Patch: Active Tryptophan, Then Sham Tryptophan | 0 | 10 |
| Total, all-cause mortality | Sham Patch: Sham Tryptophan, Then Active Tryptophan | 0 | 8 |
| Total, other adverse events | Active Patch: Active Tryptophan, Then Sham Tryptophan | 0 | 14 |
| Total, other adverse events | Active Patch: Sham Tryptophan, Then Active Tryptophan | 0 | 15 |
| Total, other adverse events | Sham Patch: Active Tryptophan, Then Sham Tryptophan | 0 | 10 |
| Total, other adverse events | Sham Patch: Sham Tryptophan, Then Active Tryptophan | 0 | 8 |
| Total, serious adverse events | Active Patch: Active Tryptophan, Then Sham Tryptophan | 0 | 14 |
| Total, serious adverse events | Active Patch: Sham Tryptophan, Then Active Tryptophan | 0 | 15 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers5
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P50MH099910 | Prepubertal Stress, Windows of Risk & Sex Bias for Affective Disturbance | EPPERSON, C. NEILL | UNIVERSITY OF PENNSYLVANIA | NATIONAL INSTITUTE OF MENTAL HEALTH | 2012 to 2017 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01208324
GET https://conductscience.org/api/trials/v1/NCT01208324/flow?page=2