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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00206544
Registration number
NCT00206544
Ethics application status
Date submitted
13/09/2005
Date registered
21/09/2005
Date last updated
24/10/2008
Titles & IDs
Public title
Anti-Estrogens - A Potential Treatment for Bipolar Affective Disorder in Women?
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Scientific title
Anti-Estrogens - A Potential Treatment for Bipolar Affective Disorder in Women?
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Secondary ID [1]
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03T-415
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Secondary ID [2]
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APRC 77/02
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Bipolar Disorder
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Mania
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Schizoaffective Disorder
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Condition category
Condition code
Mental Health
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Other mental health disorders
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Mental Health
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Depression
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Mental Health
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Psychosis and personality disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tamoxifen
Treatment: Drugs - Progesterone
Other interventions - placebo
Active comparator: 1 - Tamoxifen 40 mg daily
Active comparator: 2 - Progesterone 20 mg daily
Placebo comparator: 3 - Placebo daily
Treatment: Drugs: Tamoxifen
40 mg daily of adjunctive tamoxifen in oral capsule
Treatment: Drugs: Progesterone
20 mg daily of adjunctive progesterone in oral capsule
Other interventions: placebo
adjunctive placebo daily in oral capsule
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Scores on CARS-M Scale at trial completion
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Assessment method [1]
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Timepoint [1]
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Baseline and weeks 1, 2, 3 and 4
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Secondary outcome [1]
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Scores on PANSS at trial completion (4 weeks)
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Assessment method [1]
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Timepoint [1]
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Baseline and weeks 1, 2, 3 and 4
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Secondary outcome [2]
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Scores on MADRS at trial completion (4 weeks)
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Assessment method [2]
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Timepoint [2]
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Baseline and weeks 1, 2, 3 and 4
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Secondary outcome [3]
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Scores on Adverse Symptom Checklist at trial completion (4 weeks)
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Assessment method [3]
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Timepoint [3]
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Baseline and weeks 1, 2, 3 and 4
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Secondary outcome [4]
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Change in hormone levels over trial duration
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Assessment method [4]
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Timepoint [4]
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Baseline and weeks 1, 2, 3 and 4
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Secondary outcome [5]
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Scores on RBANS at trial completion (4 weeks)
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Assessment method [5]
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Timepoint [5]
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Baseline and week 4
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Eligibility
Key inclusion criteria
* Female patients who have a current diagnosis of Bipolar Affective Disorder (Manic phase) or Schizoaffective Disorder (Bipolar type in manic phase).
* Female patients who are able to give informed consent.
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Minimum age
18
Years
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Maximum age
50
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Female patients who are pregnant or lactating.
* Female patients with postpartum psychosis or related disorder.
* Female patients with known abnormalities in the hypothalamo-pituitary gonadal-axis, thyroid dysfunction, central nervous system tumors.
* Female patients taking estrogen preparations such as the oral contraceptive pill.
* Female patients currently taking interacting drugs including warfarin, aminoglutethimide, diuretics, methyldopa, theophylline, fluoxetine, calcium channel blockers and non-steroidal anti-inflammatory drugs.
* Female patients whose psychotic illness is directly due to illicit drugs or who have a history of substance abuse or dependence during the last 6 months.
* Females with any significant unstable medical illness such as cardiovascular disease, renal disease, Addisons disease, thromboembolic disorders, epilepsy, diabetes etc.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2007
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Sample size
Target
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Accrual to date
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Final
51
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Bayside Health - The Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
The Alfred
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Stanley Medical Research Institute
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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National Health and Medical Research Council, Australia
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
OBJECTIVE: To test the use of two adjunctive hormonal agents in a 28 day three-arm, double-blind, placebo-controlled study in the treatment of acute mania/hypomania. HYPOTHESIS: That women receiving adjunctive Tamoxifen or Progesterone will demonstrate a more rapid and more substantial decrease in manic symptoms over the course of the study than women receiving adjunctive placebo. STUDY POPULATION: Sixty females with a current diagnosis of Bipolar Affective Disorder or Schizoaffective disorder - Manic Phase, according to the operationalised criteria of the Diagnostic and Statistical Manual, 4th edition (DSM-IV) of the American Psychiatric Association. STUDY MEDICATION: Tamoxifen. One third of patients (twenty) will be randomized to receive adjunctive Tamoxifen at 40 mg/day for 28 days. The Tamoxifen will be administered within a plain capsule to maintain "blinding" of treatment arm. Progesterone. One third of patients (twenty) will be randomized to receive adjunctive oral Provera (progesterone) at 20 mg/day. The Progesterone will be administered within a plain capsule identical to that used with Tamoxifen. Placebo. The remaining one third of patients will be randomized to receive adjunctive placebo (inert substance). The placebo substance will be administered within a plain capsule identical to that used with Tamoxifen and Progesterone. STUDY EVALUATIONS: Data will be collected over a 28-day period for each patient. Visits will be performed at baseline, and then at weekly intervals. A total of five visits will be completed for each patient. The following evaluations will be performed: * Psychiatric evaluation to determine diagnosis. (Baseline visit only) * General clinical evaluation including medical history, current conditions and a non-invasive physical examination, body weight, vital signs. (Baseline visit only) * Medication history (baseline and evaluation visits). * Demographics (baseline visits only). * Completion of clinical rating scales; CARS-M, PANSS, MADRS, AIMS, Barnes Akathisia scale (BA), and Simpson-Angus scale (SA) (baseline and evaluation visits). A Menstrual Cycle Interview and a cognitive assessment (RBANS) will be performed at baseline and endpoint (day 28) visit. * Laboratory tests including; Serum levels of mood stabilizer, luteinizing hormone (LH), follicle-stimulating hormone (FSH), Estrogen, Progesterone, Prolactin, dehydroepiandrosterone (DHEA), Testosterone and protein kinase C(PKC) (baseline and evaluation visits). * Inclusion/exclusion checklist (baseline visit only). * Informed consent (baseline visit only).
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Trial website
https://clinicaltrials.gov/study/NCT00206544
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Jayashri Kulkarni, MBBS, MPM, FRANZCP, PhD
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Address
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Bayside Health / Monash University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00206544
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