A Definitive Estrogen Patch Study (ADEPT)

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Jayashri Kulkarni, Professor, The Alfred
ClinicalTrials.gov Identifier:
NCT00357006
First received: July 26, 2006
Last updated: May 7, 2015
Last verified: May 2015
Results First Received: March 1, 2015  
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: Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorder(Not in Manic Phase)
Interventions: Drug: Estradiol
Other: placebo

  Participant Flow
  Hide Participant Flow

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
  Hide Baseline Characteristics

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  
Number of Participants  
[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.   Safety Issue:   No

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

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.   Safety Issue:   Yes

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.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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
Study First Received: July 26, 2006
Results First Received: March 1, 2015
Last Updated: May 7, 2015
Health Authority: Australia: Human Research Ethics Committee