Anti-Estrogens - A Potential Treatment for Bipolar Affective Disorder in Women?
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.
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.
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.
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.
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).
|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:||Anti-Estrogens - A Potential Treatment for Bipolar Affective Disorder in Women?|
- Scores on CARS-M Scale at trial completion [ Time Frame: Baseline and weeks 1, 2, 3 and 4 ]
- Scores on PANSS at trial completion (4 weeks) [ Time Frame: Baseline and weeks 1, 2, 3 and 4 ]
- Scores on MADRS at trial completion (4 weeks) [ Time Frame: Baseline and weeks 1, 2, 3 and 4 ]
- Scores on Adverse Symptom Checklist at trial completion (4 weeks) [ Time Frame: Baseline and weeks 1, 2, 3 and 4 ]
- Change in hormone levels over trial duration [ Time Frame: Baseline and weeks 1, 2, 3 and 4 ]
- Scores on RBANS at trial completion (4 weeks) [ Time Frame: Baseline and week 4 ]
|Study Start Date:||January 2004|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Tamoxifen 40 mg daily
40 mg daily of adjunctive tamoxifen in oral capsule
Active Comparator: 2
Progesterone 20 mg daily
20 mg daily of adjunctive progesterone in oral capsule
Placebo Comparator: 3
adjunctive placebo daily in oral capsule
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|Bayside Health - The Alfred Hospital|
|Melbourne, Victoria, Australia, 3004|
|Principal Investigator:||Jayashri Kulkarni, MBBS, MPM, FRANZCP, PhD||Bayside Health / Monash University|