Anti-Estrogens - A Potential Treatment for Bipolar Affective Disorder in Women?
Status:
Completed
Trial end date:
2007-12-01
Target enrollment:
Participant gender:
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).
Phase:
Phase 2
Details
Lead Sponsor:
The Alfred
Collaborators:
National Health and Medical Research Council, Australia Stanley Medical Research Institute