Anti-Estrogens - A Potential Treatment for Bipolar Affective Disorder in Women?

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).

Conditions

• Bipolar Disorder
• Mania
• Schizoaffective Disorder

Interventions

DRUG

Tamoxifen

40 mg daily of adjunctive tamoxifen in oral capsule

DRUG

Progesterone

20 mg daily of adjunctive progesterone in oral capsule

OTHER

placebo

adjunctive placebo daily in oral capsule

Sponsors & Collaborators

• Stanley Medical Research Institute

  collaborator OTHER

• National Health and Medical Research Council, Australia

  collaborator OTHER

• The Alfred

  lead OTHER

Principal Investigators

• Jayashri Kulkarni, MBBS, MPM, FRANZCP, PhD · Bayside Health / Monash University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-01-31

Primary Completion

2007-12-31

Completion

2007-12-31

Countries

• Australia

Study Locations