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A Definitive Estrogen Patch Study (ADEPT)

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. Identifier: NCT00357006
Recruitment Status : Completed
First Posted : July 27, 2006
Results First Posted : April 1, 2015
Last Update Posted : May 12, 2015
Stanley Medical Research Institute
Information provided by (Responsible Party):
Jayashri Kulkarni, Professor, The Alfred

Brief Summary:


To test the use of adjunctive estrogen in a 8 week, three-arm, double-blind, placebo-controlled study in the treatment of psychotic symptoms in women with schizophrenia.


That women receiving adjunctive estrogen will demonstrate significantly greater improvements in the symptoms of schizophrenia than women receiving adjunctive placebo.


180 women will be recruited over a three-year period across three sites. Participant will be of potential child-bearing age (Pre-menopausal and Post-menarche) with a current diagnosis of Schizophrenia, Schizophreniform Disorder, or Schizoaffective Disorder (not in manic phase)according to the Mini International Neuropsychiatric Interview (MINI).


Estradiol. One third of the participants (n=60) will be randomised to receive adjunctive 100mcg Estradiol; one third of the participants (n=60) will be randomised to receive adjunctive 200mcg Estradiol n=60; and, one third of the participants (n=60) will be randomised to receive adjunctive placebo n=60). All patches will be covered with identical adhesive contact to ensure the "blind" is maintained.


Data will be collected over a two-month period for each participant. Visits will be performed at baseline, and then at weekly or fortnightly intervals. A total of six visits will be completed for each participant. The following evaluations will be performed:

i) Inclusion/exclusion checklist. (Baseline visit only)

ii) Informed consent. (Baseline visit only)

iii)psychiatric evaluation to determine diagnosis. (Baseline visit only)

iv) General clinical evaluation including medical history, current conditions and a non-invasive physical examination, body weight, vital signs. (Baseline and endpoint visits)

v) Medication history. (Baseline and evaluation visits)

vi) Demographics. (Baseline visits only)

vii) The primary outcome measures will be the Positive and Negative Syndrome Scale (PANSS), which will be taken at weeks 1, 2, 4 and 8 of the trial. Cognitive testing will take place at baseline and 8 weeks. Side effects will be assessed at weeks 1, 2, 4, 6, and 8 to measure changes in subject's reported side effects during the trial.

viii) Laboratory tests including; Serum levels of mood stabiliser, LH, FSH, Estrogen, Progesterone, Prolactin, DHEA,Testosterone and(Baseline and evaluation visits).

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Schizophreniform Disorder(Not in Manic Phase) Drug: Estradiol Other: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multisite Double-Blind Randomized Controlled Study of Estradiol Plus Antipsychotic Versus Placebo Plus Antipsychotic in the Treatment of Psychotic Symptoms in Women With Schizophrenia
Study Start Date : July 2006
Actual Primary Completion Date : October 2011
Actual Study Completion Date : December 2013

Arm Intervention/treatment
Active Comparator: 1
100 mcg Estradiol
Drug: Estradiol
100 mcg adjunctive transdermal estradiol

Active Comparator: 2
200 mcg Estradiol
Drug: Estradiol
200 mcg adjunctive transdermal estradiol

Placebo Comparator: 3
adjunctive transdermal placebo
Other: placebo
adjunctive transdermal placebo

Primary Outcome Measures :
  1. Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Baseline and week 8 ]
    The Positive and Negative Syndrome Scale (PANSS) is a well validated, standardized method of evaluating and monitoring psychotic symptoms. The PANSS assesses: positive (hallucinations, delusions, thought disorder), negative (blunted affect, abstract thinking and general symptomatology. The positive and negative subscale each consist of 7 items rated from 1(absent) - 7(extreme) with a minimum score = 7, maximum score = 49. The general subscale consists of 16 items with a minimum score = 16, maximum score = 112. A Total PANSS score (positive+ negative + general scores) has a minimum of 30 and maximum of 210. Higher scores represent more severity in symptoms.

Secondary Outcome Measures :
  1. Cognitive Performance (RBANS Scores) [ Time Frame: baseline and week 8 ]
  2. Scores on MADRS at Trial Completion [ Time Frame: Baseline and week 8 ]
  3. Scores on Adverse Symptom Checklist at Trial Completion [ Time Frame: Baseline and weeks 1, 2, 4, 6, 8 ]
  4. Change in Hormone Levels Over Trial Duration [ Time Frame: Baseline and weeks 1, 4 and 8. ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Female participants of potential child-bearing age (Pre-menopausal and Post-menarche)
  • Female participants who meet the MINI (Mini International Neuropsychiatric Interview for DSM-IV) diagnostic criteria for current psychotic disorder or have a current DSM-IV diagnosis of Schizophrenia, Schizophreniform Disorder, or Schizoaffective Disorder (not in manic phase).
  • Female participants with a PANSS positive score greater than 15 and/or a PANSS negative score greater than 15.
  • Female participants who are able to give informed consent
  • Female participants receiving 2-20mg daily Risperidone equivalents for at least 4 weeks.

Exclusion Criteria:

  • Female participants who are pregnant or lactating.
  • Female participants with known severe abnormalities in the hypothalamo-pituitary gonadal axis, thyroid dysfunction, central nervous system tumours, history of thromboembolic disorders, severe renal failure, severe hepatic failure, cardiac disease, epilepsy or other serious medical conditions which would contraindicate estrogen use.
  • Female participants already taking oral estrogen preparations containing greater then 30mcg estradiol.
  • Post-menopausal or pre-menarche female participants.
  • Female participants whose psychotic illness meets DSM-IV criteria for substance-induced psychotic disorder.
  • Female participants who have a current diagnosis of Schizoaffective Disorder and are in a manic phase.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00357006

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Australia, Victoria
Bayside Health - The Alfred Hospital
Melbourne, Victoria, Australia, 3181
Sponsors and Collaborators
The Alfred
Stanley Medical Research Institute
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Principal Investigator: Jayashri Kulkarni, MBBS, MPM, FRANZCP, PhD Bayside Health / Monash University
Additional Information:
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Responsible Party: Jayashri Kulkarni, Professor, Director, The Alfred Identifier: NCT00357006    
Other Study ID Numbers: 202/04
First Posted: July 27, 2006    Key Record Dates
Results First Posted: April 1, 2015
Last Update Posted: May 12, 2015
Last Verified: May 2015
Keywords provided by Jayashri Kulkarni, Professor, The Alfred:
Additional relevant MeSH terms:
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Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Polyestradiol phosphate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female