Status:
COMPLETED
Anti-Estrogens - A Potential Treatment for Bipolar Affective Disorder in Women?
Lead Sponsor:
The Alfred
Collaborating Sponsors:
Stanley Medical Research Institute
National Health and Medical Research Council, Australia
Conditions:
Bipolar Disorder
Mania
Eligibility:
FEMALE
18-50 years
Phase:
PHASE2
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 receivin...
Detailed Description
BACKGROUND: Bipolar Affective Disorder remains an illness with high morbidity and mortality. Mood stabilizers such as lithium and sodium valproate have been described as having their anti-manic effec...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00206544
Start Date
January 1 2004
End Date
December 1 2007
Last Update
October 24 2008
Active Locations (1)
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1
Bayside Health - The Alfred Hospital
Melbourne, Victoria, Australia, 3004