A Definitive Estrogen Patch Study (ADEPT)

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Alfred
• Collaborator: Stanley Medical Research Institute
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Estrogens; Polyestradiol phosphate

Criteria

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.