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Raloxifene and Rimostil for Perimenopause-Related Depression

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ClinicalTrials.gov Identifier: NCT00030147
Recruitment Status : Completed
First Posted : February 7, 2002
Results First Posted : September 5, 2016
Last Update Posted : September 5, 2016
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Perimenopausal Depression
Depression
Interventions Drug: Raloxifene
Drug: Rimostil
Drug: Transdermal Estradiol
Drug: Placebo skin patch and placebo tablets
Enrollment 65

Recruitment Details  
Pre-assignment Details Two participants signed the consent but were not started (did not meet inclusion criteria.)
Arm/Group Title Estradiol Placebo Raloxifene Rimostil
Hide Arm/Group Description Transdermal estradiol 17-beta estradiol 100 micrograms a day by skin patch and placebo tablets for eight weeks Placebo skin patch and placebo tablets for eight weeks Raloxifene (Evista) 60 mg per day and placebo skin patch for eight weeks Rimostil (phytoestrogen) 1000mg twice a day and placebo skin patch for eight weeks
Period Title: Overall Study
Started 17 19 16 11
Completed 17 18 16 11
Not Completed 0 1 0 0
Arm/Group Title Estradiol Placebo Raloxifene Rimostil Total
Hide Arm/Group Description Transdermal estradiol 17-beta estradiol 100 micrograms a day by skin patch and placebo tablets for eight weeks Placebo skin patch and placebo tablets for eight weeks Raloxifene (Evista) 60 mg per day and placebo skin patch for eight weeks Rimostil (phytoestrogen) 1000mg twice a day and placebo skin patch for eight weeks Total of all reporting groups
Overall Number of Baseline Participants 17 19 16 11 63
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 19 participants 16 participants 11 participants 63 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
 100.0%
19
 100.0%
16
 100.0%
11
 100.0%
63
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 19 participants 16 participants 11 participants 63 participants
Female
17
 100.0%
19
 100.0%
16
 100.0%
11
 100.0%
63
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 19 participants 16 participants 11 participants 63 participants
Hispanic or Latino
1
   5.9%
3
  15.8%
2
  12.5%
0
   0.0%
6
   9.5%
Not Hispanic or Latino
15
  88.2%
16
  84.2%
14
  87.5%
10
  90.9%
55
  87.3%
Unknown or Not Reported
1
   5.9%
0
   0.0%
0
   0.0%
1
   9.1%
2
   3.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 19 participants 16 participants 11 participants 63 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   5.3%
0
   0.0%
1
   9.1%
2
   3.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
  23.5%
7
  36.8%
1
   6.3%
0
   0.0%
12
  19.0%
White
13
  76.5%
9
  47.4%
13
  81.3%
9
  81.8%
44
  69.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
2
  10.5%
2
  12.5%
1
   9.1%
5
   7.9%
1.Primary Outcome
Title Center for Epidemiologic Studies–Depression Scale (CES-D)
Hide Description 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.
Time Frame Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included those subjects who started the study.
Arm/Group Title Estradiol Placebo Raloxifene Rimostil
Hide Arm/Group Description:
Transdermal estradiol 17-beta estradiol 100 micrograms a day by skin patch and placebo tablets for eight weeks
Placebo skin patch and placebo tablets for eight weeks
Raloxifene (Evista) 60 mg per day and placebo skin patch for eight weeks
Rimostil (phytoestrogen) 1000mg twice a day and placebo skin patch for eight weeks
Overall Number of Participants Analyzed 17 19 16 11
Mean (Standard Deviation)
Unit of Measure: Units on a scale
27.4  (5.76) 29.1  (9) 28.8  (7.9) 24.6  (5.5)
2.Primary Outcome
Title Center for Epidemiologic Studies–Depression Scale (CES-D)
Hide Description 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.
Time Frame Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analyses included those subjects who completed eight weeks of study
Arm/Group Title Estradiol Placebo Raloxifene Rimostil
Hide Arm/Group Description:
Transdermal estradiol 17-beta estradiol 100 micrograms a day by skin patch and placebo tablets for eight weeks
Placebo skin patch and placebo tablets for eight weeks
Raloxifene (Evista) 60 mg per day and placebo skin patch for eight weeks
Rimostil (phytoestrogen) 1000mg twice a day and placebo skin patch for eight weeks
Overall Number of Participants Analyzed 16 17 16 11
Mean (Standard Deviation)
Unit of Measure: Units on a scale
9.6  (9.4) 10.5  (11.3) 15.8  (8.9) 16.1  (8.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Estradiol Placebo Raloxifene Rimostil
Hide Arm/Group Description Transdermal estradiol 17-beta estradiol 100 micrograms a day by skin patch and placebo tablets for eight weeks Placebo skin patch and placebo tablets for eight weeks Raloxifene (Evista) 60 mg per day and placebo skin patch for eight weeks Rimostil (phytoestrogen) 1000mg twice a day and placebo skin patch for eight weeks
All-Cause Mortality
Estradiol Placebo Raloxifene Rimostil
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Estradiol Placebo Raloxifene Rimostil
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/19 (0.00%)   0/16 (0.00%)   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Estradiol Placebo Raloxifene Rimostil
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/17 (5.88%)   2/19 (10.53%)   1/16 (6.25%)   0/11 (0.00%) 
Immune system disorders         
Allergic reaction   0/17 (0.00%)  1/19 (5.26%)  0/16 (0.00%)  0/11 (0.00%) 
Musculoskeletal and connective tissue disorders         
Chest wall pain   0/17 (0.00%)  0/19 (0.00%)  1/16 (6.25%)  0/11 (0.00%) 
Pain in extremity   0/17 (0.00%)  0/19 (0.00%)  1/16 (6.25%)  0/11 (0.00%) 
Reproductive system and breast disorders         
Breast pain   0/17 (0.00%)  1/19 (5.26%)  0/16 (0.00%)  0/11 (0.00%) 
Skin and subcutaneous tissue disorders         
Rash maculo-papular   1/17 (5.88%)  0/19 (0.00%)  0/16 (0.00%)  0/11 (0.00%) 
Indicates events were collected by systematic assessment
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Schmidt, Peter
Organization: National Institute of Mental Health
Phone: +1 301 496 6120
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
ClinicalTrials.gov Identifier: NCT00030147     History of Changes
Other Study ID Numbers: 020120
ZIAMH002537-26 ( U.S. NIH Grant/Contract )
02-M-0120 ( Other Identifier: NIHCC )
First Submitted: February 6, 2002
First Posted: February 7, 2002
Results First Submitted: June 2, 2016
Results First Posted: September 5, 2016
Last Update Posted: September 5, 2016