Trial · NCT00030147
Raloxifene and Rimostil for Perimenopause-Related Depression
NCT00030147, Phase 4, Completed, National Institute of Mental Health (NIMH); results first posted 2016-09-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Raloxifene and Rimostil for Perimenopause-Related Depression. Trials, record NCT00030147. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00030147
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Raloxifene and Rimostil for Perimenopause-Related Depression
- NCT number
- NCT00030147
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 65 participants, actual
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Conditions
- Perimenopausal Depression, Depression
- Interventions
- Raloxifene, Rimostil, Transdermal Estradiol, Placebo skin patch and placebo tablets
- First posted
- 2002-02-07
- Last updated
- 2016-09-05
- Results first posted
- 2016-09-05
- Limitations and caveats
- Two participants signed the consent but were not started (did not meet inclusion criteria.) Early termination of Rimostil treatment arm limits the generalizability of treatment response in this arm.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Center for Epidemiologic Studies-Depression Scale (CES-D) | Baseline | Center for Epidemiologic Studies-Depression Scale (CES-D) cutoff scores are typically used as a screen to identify clinically significant depression; a cutoff score of greater than 16 has been shown to correlate with clinically significant depression. In addition, a score between 8 and 15 has been used to define subsyndromal depression. The possible range of scores is zero to 60, with the higher scores indicating more symptoms, weighted by frequency of occurrence during the past week. |
| Primary | Center for Epidemiologic Studies-Depression Scale (CES-D) | Week 8 | Center for Epidemiologic Studies-Depression Scale (CES-D) cutoff scores are typically used as a screen to identify clinically significant depression; a cutoff score of greater than 16 has been shown to correlate with clinically significant depression. In addition, a score between 8 and 15 has been used to define subsyndromal depression. The possible range of scores is zero to 60, with the higher scores indicating more symptoms, weighted by frequency of occurrence during the past week. |
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 | Center for Epidemiologic Studies-Depression Scale (CES-D) | Baseline | The analyses included those subjects who started the study. | Units on a scale | MEAN |
| PRIMARY | Center for Epidemiologic Studies-Depression Scale (CES-D) | Week 8 | The analyses included those subjects who completed eight weeks of study | Units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Center for Epidemiologic Studies-Depression Scale (CES-D) | Estradiol | 27.4 | Standard Deviation 5.76 | Units on a scale | |
| Center for Epidemiologic Studies-Depression Scale (CES-D) | Placebo | 29.1 | Standard Deviation 9 | Units on a scale | |
| Center for Epidemiologic Studies-Depression Scale (CES-D) | Raloxifene | 28.8 | Standard Deviation 7.9 | Units on a scale | |
| Center for Epidemiologic Studies-Depression Scale (CES-D) | Rimostil | 24.6 | Standard Deviation 5.5 | Units on a scale | |
| Center for Epidemiologic Studies-Depression Scale (CES-D) | Estradiol | 9.6 | Standard Deviation 9.4 | Units on a scale | |
| Center for Epidemiologic Studies-Depression Scale (CES-D) | Placebo | 10.5 | Standard Deviation 11.3 | Units on a scale | |
| Center for Epidemiologic Studies-Depression Scale (CES-D) | Raloxifene | 15.8 | Standard Deviation 8.9 | Units on a scale | |
| Center for Epidemiologic Studies-Depression Scale (CES-D) | Rimostil | 16.1 | Standard Deviation 8.8 | Units on a scale |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Estradiol | 17 | |
| Overall Study | STARTED | Placebo | 19 | |
| Overall Study | STARTED | Raloxifene | 16 | |
| Overall Study | STARTED | Rimostil | 11 | |
| Overall Study | COMPLETED | Estradiol | 17 | |
| Overall Study | COMPLETED | Placebo | 18 | |
| Overall Study | COMPLETED | Raloxifene | 16 | |
| Overall Study | COMPLETED | Rimostil | 11 | |
| Overall Study | NOT COMPLETED | Estradiol | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events20
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Allergic reaction | Immune system disorders | Estradiol | 0 | 17 | |
| other | Allergic reaction | Immune system disorders | Placebo | 1 | 19 | |
| other | Allergic reaction | Immune system disorders | Raloxifene | 0 | 16 | |
| other | Allergic reaction | Immune system disorders | Rimostil | 0 | 11 | |
| other | Chest wall pain | Musculoskeletal and connective tissue disorders | Estradiol | 0 | 17 | |
| other | Chest wall pain | Musculoskeletal and connective tissue disorders | Placebo | 0 | 19 | |
| other | Chest wall pain | Musculoskeletal and connective tissue disorders | Raloxifene | 1 | 16 | |
| other | Chest wall pain | Musculoskeletal and connective tissue disorders | Rimostil | 0 | 11 | |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Estradiol | 0 | 17 | |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Placebo | 0 | 19 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Estradiol | ||
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Raloxifene | ||
| Total, all-cause mortality | Rimostil | ||
| Total, other adverse events | Estradiol | 1 | 17 |
| Total, other adverse events | Placebo | 2 | 19 |
| Total, other adverse events | Raloxifene | 1 | 16 |
| Total, other adverse events | Rimostil | 0 | 11 |
| Total, serious adverse events | Estradiol | 0 | 17 |
| Total, serious adverse events | Placebo | 0 | 19 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33470755 | DERIVED |
Source PubMed
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 |
|---|---|---|---|---|---|
| ZIAMH002537 | Psychobiology and Treatment of Perimenopausal Mood Disorders | SCHMIDT, PETER | NATIONAL INSTITUTE OF MENTAL HEALTH | NATIONAL INSTITUTE OF MENTAL HEALTH | 2009 to 2025 |
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/NCT00030147
GET https://conductscience.org/api/trials/v1/NCT00030147/registered