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A Definitive Estrogen Patch Study (ADEPT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00357006
First Posted: July 27, 2006
Last Update Posted: May 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Jayashri Kulkarni, Professor, The Alfred
Results First Submitted: March 1, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorder(Not in Manic Phase)
Interventions: Drug: Estradiol
Other: placebo

  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
Between 2006 and 2011, a total of 1858 women were assessed for eligibility, of which 204 were screened from inpatient and outpatient settings across three Australian sites (Alfred, a tertiary referral centre; Barwon, a rural centre; and Dandenong, an outer metropolitan centre) over a 5-year period and completed a 56-day trial.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Adjunctive 200 mcg Transdermal Estradiol Participants received daily 200mcg transdermal estradiol for 56 days.
Adjunctive 100 mcg Transdermal Estradiol Participants received daily 100mcg transdermal estradiol for 56 days.
Placebo Participants received daily transdermal placebo for 56 days.

Participant Flow:   Overall Study
    Adjunctive 200 mcg Transdermal Estradiol   Adjunctive 100 mcg Transdermal Estradiol   Placebo
STARTED   62   56   62 
COMPLETED   60   51   59 
NOT COMPLETED   2   5   3 
Lost to Follow-up                1                2                1 
Withdrawal by Subject                1                3                2 



  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
Adjunctive 200 mcg Transdermal Estradiol No text entered.
Adjunctive 100 mcg Transdermal Estradiol No text entered.
Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
   Adjunctive 200 mcg Transdermal Estradiol   Adjunctive 100 mcg Transdermal Estradiol   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 62   56   62   180 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   62   56   62   180 
>=65 years   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 35.29  (8.14)   34.77  (7.28)   35.44  (8.46)   35.18  (7.96) 
Gender 
[Units: Participants]
       
Female   62   56   62   180 
Male   0   0   0   0 
Region of Enrollment 
[Units: Participants]
       
Australia   62   56   62   180 


  Outcome Measures

1.  Primary:   Positive and Negative Syndrome Scale (PANSS)   [ Time Frame: Baseline and week 8 ]

2.  Secondary:   Cognitive Performance (RBANS Scores)   [ Time Frame: baseline and week 8 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Scores on MADRS at Trial Completion   [ Time Frame: Baseline and week 8 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Scores on Adverse Symptom Checklist at Trial Completion   [ Time Frame: Baseline and weeks 1, 2, 4, 6, 8 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Change in Hormone Levels Over Trial Duration   [ Time Frame: Baseline and weeks 1, 4 and 8. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Prof Jayashri Kulkarni
Organization: Monash Alfred Psychiatry Research Centre
phone: +61 390766924 ext 66924
e-mail: j.kulkarni@alfred.org.au



Responsible Party: Jayashri Kulkarni, Professor, The Alfred
ClinicalTrials.gov Identifier: NCT00357006     History of Changes
Other Study ID Numbers: 202/04
05T-742
First Submitted: July 26, 2006
First Posted: July 27, 2006
Results First Submitted: March 1, 2015
Results First Posted: April 1, 2015
Last Update Posted: May 12, 2015