Raloxifene in Treatment of Schizophrenia and Schizoaffective Disorder

Summary

The objective of the study is to evaluate the efficacy of raloxifene compared to placebo, as add-on to anti-psychotics in the treatment of post menopausal patients with schizophrenia.

Timeline

Start

2011-03

Primary completion

2012-12

Completion

2013-03

Outcome

Missed primary endpoint

paper with results favoring placebo by 4.5 points (95% CI, 2.3-6.7). PMID 28541645 ↗

paper results unequivocally show no benefit of antipsychotics plus raloxifene versus antipsychotics plus placebo PMID 28541645 ↗

Publications

• Weiser M, Levi L, Burshtein S, Hagin M, Matei VP, Podea D, Miclutia I, Tiugan A, Pacala B, Grecu IG, Noy A, Zamora D, Davis JM. Raloxifene Plus Antipsychotics Versus Placebo Plus Antipsychotics in Severely Ill Decompensated Postmenopausal Women With Schizophrenia or Schizoaffective Disorder: A Randomized Controlled Trial. J Clin Psychiatry. 2017 Jul;78(7):e758-e765. doi: 10.4088/JCP.15m10498.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Raloxifene	Other / unclassified	60 mg	—

Indications