A Definitive Estrogen Patch Study (ADEPT)

Summary

OBJECTIVE:

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.

HYPOTHESIS:

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

STUDY POPULATION:

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).

STUDY MEDICATION:

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.

STUDY EVALUATIONS:

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).

Conditions

• Schizophrenia
• Schizoaffective Disorder
• Schizophreniform Disorder(Not in Manic Phase)

Interventions

DRUG

Estradiol

100 mcg adjunctive transdermal estradiol

DRUG

Estradiol

200 mcg adjunctive transdermal estradiol

OTHER

placebo

adjunctive transdermal placebo

Sponsors & Collaborators

• Stanley Medical Research Institute

  collaborator OTHER

• The Alfred

  lead OTHER

Principal Investigators

• Jayashri Kulkarni, MBBS, MPM, FRANZCP, PhD · Bayside Health / Monash University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-07-31

Primary Completion

2011-10-31

Completion

2013-12-31

Countries

• Australia

Study Locations