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Raloxifene and Rimostil for Perimenopause-Related Depression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
ClinicalTrials.gov Identifier:
NCT00030147
First received: February 6, 2002
Last updated: July 18, 2016
Last verified: July 2016
Results First Received: June 2, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two participants signed the consent but were not started (did not meet inclusion criteria.)

Reporting Groups
  Description
Estradiol Transdermal estradiol 17-beta estradiol 100 micrograms a day by skin patch and placebo tablets for eight weeks
Placebo Placebo skin patch and placebo tablets for eight weeks
Raloxifene Raloxifene (Evista) 60 mg per day and placebo skin patch for eight weeks
Rimostil Rimostil (phytoestrogen) 1000mg twice a day and placebo skin patch for eight weeks

Participant Flow:   Overall Study
    Estradiol   Placebo   Raloxifene   Rimostil
STARTED   17   19   16   11 
COMPLETED   17   18   16   11 
NOT COMPLETED   0   1   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Estradiol Transdermal estradiol 17-beta estradiol 100 micrograms a day by skin patch and placebo tablets for eight weeks
Placebo Placebo skin patch and placebo tablets for eight weeks
Raloxifene Raloxifene (Evista) 60 mg per day and placebo skin patch for eight weeks
Rimostil Rimostil (phytoestrogen) 1000mg twice a day and placebo skin patch for eight weeks
Total Total of all reporting groups

Baseline Measures
   Estradiol   Placebo   Raloxifene   Rimostil   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   19   16   11   63 
Age 
[Units: Participants]
         
<=18 years   0   0   0   0   0 
Between 18 and 65 years   17   19   16   11   63 
>=65 years   0   0   0   0   0 
Gender 
[Units: Participants]
         
Female   17   19   16   11   63 
Male   0   0   0   0   0 
Ethnicity (NIH/OMB) 
[Units: Participants]
         
Hispanic or Latino   1   3   2   0   6 
Not Hispanic or Latino   15   16   14   10   55 
Unknown or Not Reported   1   0   0   1   2 
Race (NIH/OMB) 
[Units: Participants]
         
American Indian or Alaska Native   0   0   0   0   0 
Asian   0   1   0   1   2 
Native Hawaiian or Other Pacific Islander   0   0   0   0   0 
Black or African American   4   7   1   0   12 
White   13   9   13   9   44 
More than one race   0   0   0   0   0 
Unknown or Not Reported   0   2   2   1   5 


  Outcome Measures
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1.  Primary:   Center for Epidemiologic Studies–Depression Scale (CES-D)   [ Time Frame: Baseline ]

2.  Primary:   Center for Epidemiologic Studies–Depression Scale (CES-D)   [ Time Frame: Week 8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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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
e-mail: peterschmidt@mail.nih.gov



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 ( US NIH Grant/Contract Award Number )
02-M-0120 ( Other Identifier: NIHCC )
Study First Received: February 6, 2002
Results First Received: June 2, 2016
Last Updated: July 18, 2016
Health Authority: United States: Federal Government
United States: Food and Drug Administration