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Tibolone vs Escitalopram in First Onset Perimenopausal Depression
NCT01368068Phase 4
Key facts
- Status
- Terminated
- Start
- Jul 2012
- Primary completion
- Jul 2012
- Countries
- 1
- Sponsor
- Alfred Health
- Modality
- Orthosteric Ligands, Metabolically Activated Prodrugs
- Drugs
- tibolone
- Conditions
- perimenopausal depression
01
Overview
Phase 4, randomised, double-blind trial of tibolone in perimenopausal depression (3 arms), sponsored by Alfred Health. Primary endpoint: Montgomery and Asberg Depression Rating Scale at 12 weeks. Started Jul 2012; status: terminated.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Tibolone
2.5 mg/day oral Tibolone
Escitalopram
10 mg/day oral Escitalopram
Placebo
Placebo (Natvia)
03
Who it enrols
Perimenopausal women (45-55) with first onset DSM-IV depression. Excludes those with past psychiatric history, severe suicidality, recent antidepressant use, smokers, and those with significant medical illness.
04
Endpoints
Primary
Montgomery and Asberg Depression Rating Scale
Secondary
Short Form-36 Health Survey
Pittsburgh Sleep Quality Index
Adverse Symptoms Checklist
Beck Depression Inventory Scale
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