Health TrialsbyHealthPanel

Bazedoxifene -Treatment for Women With Schizophrenia

ConditionsSchizophreniaSchizophreniform DisordersSchizo Affective Disorder
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorThe Alfred

About this trial

To study the effect of adjunctive bazedoxifene - a selective estrogen receptor modulator (SERM) in a double blind, placebo-controlled adjunctive study in the treatment of women with schizophrenia. All patients receive standardized antipsychotic medication.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Physically well.

A current DSM-V diagnosis of schizophrenia or related disorder.

18- 65 years

Able to give informed consent.

Disqualifiers

Patients with known abnormalities in the hypothalamo-pituitary gonadal axis, thyroid dysfunction, central nervous system tumours, active or past history of a venous thromboembolic event.

Patients with a history of severe traumatic brain injury or significant neurological or unstable medical illness such as epilepsy and diabetes or known active cardiac, renal or liver disease; presence of illness causing immobilisation.

Patients whose psychotic illness is directly related to illicit substance use or who have a history of substance dependence during the last six months (with the exclusion of caffeine and/or nicotine dependence).

Women aged 40 or over who have not had a normal mammogram in the last 24 months

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bazedoxifene Acetate

    Drug

    Oral Bazedoxifene dosed at 40 mg daily for 12 weeks

  • Placebo

    Drug

    Identically packaged placebo capsule daily

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Oral BazedoxifeneExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Schizophrenia symptoms

Psychopathology rating scales to quantify psychotic and affective symptoms (PANSS)

Time frame
12 Weeks

Secondary outcomes

1

Cognition

Cognitive test battery to quantify changes in cognitive functioning (MATRICS)

Time frame
12 Weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Alfred

Lead sponsor

Monash University

Collaborator

Source ClinicalTrials.gov
Apply now