Perimenopausal DepressionPhase 4NCT00030147

Raloxifene and Rimostil for Perimenopause-Related Depression

A Phase 4 study testing Raloxifene, Rimostil and Transdermal Estradiol in people with Perimenopausal Depression and Depression, run by National Institute of Mental Health (NIMH) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate the effectiveness of the drugs raloxifene and rimostil in treating perimenopause-related depression. Perimenopause-related mood disorders cause significant distress to a large number of women; the demand for effective therapies to treat these mood disorders is considerable. Read more about this study

Who is it for?: Ages 40 to 60 years, women only
Conditions the study is for: Perimenopausal Depression, Depression
What is being tested?: Raloxifene, Rimostil and Transdermal Estradiol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 65 participants
Where: 1 siteUnited States
Study dates: Feb 2002to Jun 2015
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 40 to 60 years
Women only
No healthy volunteers
Adult

Who may be able to join

Subjects for this study will meet the following criteria:
Self-report of the onset of depression associated with menstrual cycle irregularity or amenorrhea;
A current episode of minor (meeting 3-4 criterion symptoms) or major depression (of moderate severity or less on the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV (SCID) severity scale and not meeting DSM-IV criteria symptom 9 (suicide)) as determined by the administration of the minor depression module of the Schedule for Affective Disorders and Schizophrenia - Lifetime Version (SADS-L). Additionally, to ensure that subjects meet a minimum threshold for severity of depression, subjects will have scores greater than or equal to 10 on either the Beck Depression Inventory (BDI) or the Center for Epidemiologic Studies - Depression (CES-D) Scale during at least three of the four clinic visits during the two month screening phase, as well as a 17 item Hamilton Depression score greater than or equal to 10. Subjects will be excluded if they meet any of the following criteria: major depression of greater than moderate severity, DSM-IV criteria # 9 (suicide), or anyone requiring immediate treatment after clinical assessment or functional impairment ratings of five or six for more than seven consecutive days on daily ratings;
Evidence of perimenopausal reproductive status;
Age 40 to 60;
No prior hormonal therapy for the treatment of perimenopause-related mood or physical symptoms within the last six months;
No history of psychiatric illness during the two years prior to the reported onset of the current episode of depression;
In good medical health, and not taking any medication or dietary and herbal supplements on a regular basis (with the exception of multivitamins and calcium supplements).

Who cannot join

The following conditions will constitute contraindications to treatment and will preclude a subject s participation in this protocol:
1) Severe major depression with any of the following:
positive (threshold) response to SCID major depression section item # 9, suicidal ideation;
anyone requiring immediate treatment after clinical assessment;
severity ratings greater than moderate on the SCID IV interview;
functional impairment ratings of five or six for more than seven consecutive days on daily ratings.

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2) Current treatment with antidepressant medications. Our main concern is to exclude subjects taking medications that would treat or precipitate depression or adversely interact with reproductive hormones, phytoestrogens (e.g., anticoagulants), or SERMs. Thus, we wish to exclude only women receiving psychotropic medications, medications that have been reported to induce a change in mood or behavior, hormone replacement therapy, oral contraceptive agents, or medications that may have a potential adverse interaction with the compounds employed in this study.
3) History of psychiatric illness during the two years before the reported onset of the current episode of depression.
4) History of ischemic cardiac disease, pulmonary embolism, retinal thrombosis, or thrombophlebitis; any subject with risk factors for thrombo-embolic phenomena including cigarette smokers; varicose veins, patients with prolonged periods of immobilization (including prolonged travel), and active heart disease. The literature suggests that although both smoking and hormone replacement/oral contraceptives have associated risks of thromboembolic phenomena and cardiovascular events, these individual risks do not become significantly greater when combined until greater than 10 cigarettes a day are consumed. Thus we wish to exclude only subjects for this study who smoke greater than 10 cigarettes per day.
5) Renal disease, asthma.
6) Hepatic dysfunction.
7) Women with a history of carcinoma of the breast, or any women with a family history of the following: premenopausal breast cancer or bilateral breast cancer in a first degree relative; multiple family members (greater than three relatives) with postmenopausal breast cancer.
8) Women with a history of uterine cancer, endometriosis, ill-defined pelvic lesions, particularly undiagnosed ovarian enlargement, undiagnosed vaginal bleeding.
9) Patients with a known hypersensitivity to raloxifene, phytoestrogens (including Rimostil, isoflavones, genistein, daidzein, red clover extract and soy-related compounds), estradiol, Alora, medroxyprogesterone acetate, or the excipients (inactive compounds) contained within these medications including: Rimostil -tocopherols, cellulose, calcium hydrogen phosphate, magnesium stearate, silica-colloidal anhydrous; Provera - calcium stearate, corn starch, lactose, mineral oil, sorbic acid, sucrose, talc; Alora - sorbitan monooleate, acrylic adhesive; Evista - anhydrous lactose, carnauba wax, crospovidone, Federal Food, Drug, and Cosmetic Act (FD\& C) blue # 2 aluminum lake, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, modified pharmaceutical glaze, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide.
10) Pregnant women.
11) Porphyria.
12) Diabetes mellitus.
13) Cholecystitis or pancreatitis.
14) History of cerebrovascular disease (stroke), epilepsy, hypertension, hypercalcemia.
15) Recurrent migraine headaches.
16) Malignant melanoma.
17) History of familial hyperlipoproteinemia.

Trial locations and contacts

1 site in 1 country.

United States1 site

National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: The Efficacy of Phytoestrogens and Selective Estrogen Receptor Modulators in Perimenopause-Related Depression

The purpose of this study is to evaluate the effectiveness of the drugs raloxifene and rimostil in treating perimenopause-related depression.

Perimenopause-related mood disorders cause significant distress to a large number of women; the demand for effective therapies to treat these mood disorders is considerable. Estradiol replacement therapy (ERT) has demonstrated efficacy in treating perimenopause-related depression. Unfortunately, there are long-term risks associated with ERT. Selective estrogen receptor modulators (SERMS), such as raloxifene, and phytoestrogens, such as rimostil, have estrogen-like properties and may offer a safer alternative to ERT. The effect of SERMS and phytoestrogens on mood and cognitive functioning need to be examined in women with perimenopause-related depression.

Participants in this study will undergo a medical history, physical examination, electrocardiogram (EKG), and blood and urine tests. They will then be randomly assigned to receive one of four treatments for 8 weeks: raloxifene pills plus a placebo (an inactive substance) skin patch, rimostil pills plus placebo skin patch, estradiol skin patch plus placebo pills, or placebo patch plus placebo pills. Participants will have clinic visits every 2 weeks. During the visits, blood will be drawn and participants will meet with staff members and complete symptom self-rating scales. A urine and blood sample will be collected at the beginning and end of the study. At the end of the study, participants who received placebo or whose study medication was ineffective will be offered treatment with standard antidepressant medications for 8 weeks. Non-menstruating women will receive progesterone for 10 days to induce menstrual bleeding and shedding of the inner layer of the uterus, which may have been stimulated by the study medications.

Read the detailed description

Perimenopause-related mood disorders cause significant distress to a potentially large number of women. The demand for effective therapeutic alternatives to estrogen for treating these mood disorders is considerable, as is the need to define clinical or biologic markers that may predict successful response of mood disturbances to phytoestrogens or selective estrogen receptor modulators (SERMs). Further, the study of potential biological mechanisms underlying both perimenopause-related mood disorders and their response to treatment may offer the possibility of uncovering some etiopathogenic mechanisms involved in these and related mood disorders.

Results of protocol # 90-M-0077 demonstrated the therapeutic efficacy of estradiol therapy (ET) in perimenopausal depression, independent of its effects on vasomotor symptoms. Nevertheless, the long term risks of ET to endometrial and breast tissues continue to deter many women from its use. Recently, selective estrogen receptor modulators (SERMs) and phytoestrogens (plant-derived estrogen-like compounds) have become available and are reported to display both tissue-specific profiles of estrogen agonist and antagonist actions and differential affinities for the two forms of estrogen receptor. For many women, these novel compounds would represent a safer alternative to ET for the prevention of osteoporosis and the treatment of menopausal symptoms. However, the effects of SERMs and phytoestrogens on mood and cognitive function in perimenopausal women remain undetermined.

In this protocol we wish both to investigate the effects of SERMs and phytoestrogens on mood and cognition under placebo controlled conditions and to compare these effects with estradiol therapy. This protocol will address the following questions: 1) Do selective estrogen receptor modulators or phytoestrogens improve mood and cognition in perimenopausal depressed women? 2) Are the mood and cognitive effects of SERMs and phytoestrogens comparable to those of ET? and 3) Do selective estrogen receptor modulators and phytoestrogens improve measures of bone metabolism in perimenopausal depressed women?

Conditions: Perimenopausal Depression, Depression
Being tested: Raloxifene, Rimostil, Transdermal Estradiol, Placebo skin patch and placebo tablets
Keywords: Gonadal Steroids, Estrogen Receptor, Mood Disorders, Perimenopause, Estradiol, Depression, Estrogen Response Element, Perimenopausal, Perimenopausal Depression
Medical subject headings: Depression, Mood Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RaloxifeneDrug
Also called Evista
60 mg a day orally administered
RimostilDrug
1000 mg twice a day administered orally
Transdermal EstradiolDrug
Also called Alora
100 microgram per day transdermal estradiol
Placebo skin patch and placebo tabletsDrug
matched placebo skin patch to transdermal estradiol and matched tablets to either Raloxifene or Rimostil

Study groups in NCT00030147
Study group	Role	What they receive
Raloxifene	Experimental	Raloxifene (Evista) 60 mg per day and placebo skin patch for eight weeks Receives: Drug: Raloxifene
Rimostil	Experimental	Rimostil (phytoestrogen) 1000 mg twice a day and placebo skin patch for eight weeks Receives: Drug: Rimostil
Transdermal estradiol	Active comparator	17-beta estradiol 100 micrograms a day by skin patch and placebo tablets for eight weeks Receives: Drug: Transdermal Estradiol
Placebo	Placebo comparator	Placebo skin patch and placebo tablets for eight weeks. Receives: Drug: Placebo skin patch and placebo tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

Center for Epidemiologic Studies-Depression Scale (CES-D)
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.
Measured: Baseline
Center for Epidemiologic Studies-Depression Scale (CES-D)
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.
Measured: Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2002Jun 2015

First posted7 Feb 2002 (estimated)
Study startFeb 2002
Primary completionJun 2015
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Perimenopausal DepressionStudies of the same condition, open and under way.
More trials run by National Institute of Mental Health (NIMH)The 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00030147
Sponsor's protocol ID: 020120
Other IDs: ZIAMH002537-26, 02-M-0120
Status last verified: Jul 2016
First submitted: 6 Feb 2002
Last updated: 5 Sep 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Schmidt PJ, Wei SM, Martinez PE, Dor RRB, Guerrieri GM, Palladino PP, Harsh VL, Li HJ, Wakim P, Nieman LK, Rubinow DR. The short-term effects of estradiol, raloxifene, and a phytoestrogen in women with perimenopausal depression. Menopause. 2021 Jan 15;28(4):369-383. doi: 10.1097/GME.0000000000001724.
PubMed 33470755

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Impact of a Novel Functional Snack on Perimenopausal Symptoms and Well-being
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Probiotic Intake and Perimenopausal Psychological Assessments
Emotional Processing and Cognitive Function in Perimenopausal Women Experiencing Cognitive Perturbations, Perimenopause
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All Perimenopausal Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Efficacy of Phytoestrogens and Selective Estrogen Receptor Modulators in Perimenopause-Related Depression
ClinicalTrials.gov ID: NCT00030147
Acronym / sponsor ID: 020120
Conditions: Perimenopausal Depression, Depression
Keywords: Gonadal Steroids, Estrogen Receptor, Mood Disorders, Perimenopause, Estradiol, Depression, Estrogen Response Element, Perimenopausal
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: National Institute of Mental Health (NIMH)US National Institutes of Health
Study start: Feb 2002
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 7 Feb 2002 (estimated)
Results: Posted 5 Sep 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the effectiveness of the drugs raloxifene and rimostil in treating perimenopause-related depression.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Raloxifene	Experimental	Drug: RaloxifeneRaloxifene (Evista) 60 mg per day and placebo skin patch for eight weeks
Rimostil	Experimental	Drug: RimostilRimostil (phytoestrogen) 1000 mg twice a day and placebo skin patch for eight weeks
Transdermal estradiol	Active comparator	Drug: Transdermal Estradiol17-beta estradiol 100 micrograms a day by skin patch and placebo tablets for eight weeks
Placebo	Placebo comparator	Drug: Placebo skin patch and placebo tabletsPlacebo skin patch and placebo tablets for eight weeks.

Who may qualify

Ages: 40 to 60 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Self-report of the onset of depression associated with menstrual cycle irregularity or amenorrhea;
A current episode of minor (meeting 3-4 criterion symptoms) or major depression (of moderate severity or less on the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV (SCID) severity scale and not meeting DSM-IV criteria symptom 9 (suicide)) as determined by the administration of the minor depression module of the Schedule for Affective Disorders and Schizophrenia - Lifetime Version (SADS-L). Additionally, to ensure that subjects meet a minimum threshold for severity of depression, subjects will have scores greater than or equal to 10 on either the Beck Depression Inventory (BDI) or the Center for Epidemiologic Studies - Depression (CES-D) Scale during at least three of the four clinic visits during the two month screening phase, as well as a 17 item Hamilton Depression score greater than or equal to 10. Subjects will be excluded if they meet any of the following criteria: major depression of greater than moderate severity, DSM-IV criteria # 9 (suicide), or anyone requiring immediate treatment after clinical assessment or functional impairment ratings of five or six for more than seven consecutive days on daily ratings;
Evidence of perimenopausal reproductive status;
Age 40 to 60;
No prior hormonal therapy for the treatment of perimenopause-related mood or physical symptoms within the last six months;

Key exclusion criteria (22 listed)

The following conditions will constitute contraindications to treatment and will preclude a subject s participation in this protocol:
positive (threshold) response to SCID major depression section item # 9, suicidal ideation;
anyone requiring immediate treatment after clinical assessment;
severity ratings greater than moderate on the SCID IV interview;
functional impairment ratings of five or six for more than seven consecutive days on daily ratings.

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
RaloxifeneAlso: Evista60 mg a day orally administered	Drug	Raloxifene
Rimostil1000 mg twice a day administered orally	Drug	Rimostil
Transdermal EstradiolAlso: Alora100 microgram per day transdermal estradiol	Drug	Transdermal estradiol
Placebo skin patch and placebo tabletsmatched placebo skin patch to transdermal estradiol and matched tablets to either Raloxifene or Rimostil	Drug	Placebo

Primary outcome

Center for Epidemiologic Studies-Depression Scale (CES-D)
Time frame: 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.
Center for Epidemiologic Studies-Depression Scale (CES-D)
Time frame: 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.

Results and safety

Results posted to the registry on 5 Sep 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Estradiol	17	17
Placebo	19	18
Raloxifene	16	16
Rimostil	11	11

Primary outcome: Center for Epidemiologic Studies-Depression Scale (CES-D)

Time frame: Baseline. Mean (Standard Deviation). Unit: Units on a scale

Measure	Estradiol n = 17	Placebo n = 19	Raloxifene n = 16	Rimostil n = 11
Value	27.4 (5.76)	29.1 (9)	28.8 (7.9)	24.6 (5.5)

Population analysed: The analyses included those subjects who started the study.

Primary outcome: Center for Epidemiologic Studies-Depression Scale (CES-D)

Time frame: Week 8. Mean (Standard Deviation). Unit: Units on a scale

Measure	Estradiol n = 16	Placebo n = 17	Raloxifene n = 16	Rimostil n = 11
Value	9.6 (9.4)	10.5 (11.3)	15.8 (8.9)	16.1 (8.8)

Population analysed: The analyses included those subjects who completed eight weeks of study

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Estradiol	0 of 17 (0%)	1 of 17 (5.9%)	Not reported
Placebo	0 of 19 (0%)	2 of 19 (10.5%)	Not reported
Raloxifene	0 of 16 (0%)	1 of 16 (6.3%)	Not reported
Rimostil	0 of 11 (0%)	0 of 11 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33470755Schmidt PJ, Wei SM, Martinez PE, Dor RRB, Guerrieri GM, Palladino PP, Harsh VL, Li HJ, Wakim P, Nieman LK, Rubinow DR. The short-term effects of estradiol, raloxifene, and a phytoestrogen in women with perimenopausal depression. Menopause. 2021 Jan 15;28(4):369-383. doi: 10.1097/GME.0000000000001724.
NIH Clinical Center Detailed Web PageLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Perimenopausal Depression

Enrolling by invitationObservational study
Multidimensional Determinants of Functional Health In Women Aged 45-60
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Meleis' Transition Theory-Based Education and Counseling Program in Menopausal Women
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Impact of a Novel Functional Snack on Perimenopausal Symptoms and Well-being
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Recruiting
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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.

Peter J Schmidt, M.D. principal investigator

National Institute of Mental Health (NIMH)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 22 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: finished, as of the sponsor's last update on 5 Sep 2016. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Center for Epidemiologic Studies-Depression Scale (CES-D) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00030147, which also lists 1 linked publication.

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 5 Sep 2016.