A Definitive Estrogen Patch Study (ADEPT)

This study is ongoing, but not recruiting participants.
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: October 9, 2013
Last verified: October 2013
  Purpose

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 women 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) P

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 Intervention Phase
Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorder(Not in Manic Phase)
Drug: Estradiol
Other: placebo
Phase 2

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
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

Resource links provided by NLM:


Further study details as provided by The Alfred:

Primary Outcome Measures:
  • Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Baseline and weeks 1, 2, 4 and 8 of the trial. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cognitive performance (RBANS Scores) [ Time Frame: baseline and week 8 ] [ Designated as safety issue: No ]
  • Scores on MADRS at trial completion [ Time Frame: Baseline and weeks 1, 2, 4 and 8 ] [ Designated as safety issue: No ]
  • Scores on Adverse Symptom Checklist at trial completion [ Time Frame: Baseline and weeks 1, 2, 4, 6, 8 ] [ Designated as safety issue: Yes ]
  • Change in hormone levels over trial duration [ Time Frame: Baseline and weeks 1, 4 and 8. ] [ Designated as safety issue: No ]

Enrollment: 180
Study Start Date: July 2006
Estimated Study Completion Date: December 2013
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00357006

Locations
Australia, Victoria
Bayside Health - The Alfred Hospital
Melbourne, Victoria, Australia, 3181
Sponsors and Collaborators
The Alfred
Stanley Medical Research Institute
Investigators
Principal Investigator: Jayashri Kulkarni, MBBS, MPM, FRANZCP, PhD Bayside Health / Monash University
  More Information

Additional Information:
No publications provided

Responsible Party: Jayashri Kulkarni, Professor, Director, The Alfred
ClinicalTrials.gov Identifier: NCT00357006     History of Changes
Other Study ID Numbers: 202/04, 05T-742
Study First Received: July 26, 2006
Last Updated: October 9, 2013
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by The Alfred:
Schizophrenia
Estrogen
Psychosis

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Estradiol
Polyestradiol phosphate
Estrogens
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Antipsychotic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 23, 2014