Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00361543
Status:
COMPLETED
Last Update Posted:
2015-01-30
First Post:
2006-08-07
Brief Title:
Selective Estrogen Receptor Modulators - A Potential Treatment for Psychotic Symptoms of Schizophrenia
Sponsor:
The Alfred
Organization:
The Alfred
Study Overview
Official Title:
Selective Estrogen Receptor Modulators - A Potential Treatment for Psychotic Symptoms of Schizophrenia
Status:
COMPLETED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SERM
Brief Summary:
The aim of the project is to investigate the use of Raloxifene a new form of estrogen in the treatment of women with schizophrenia and schizoaffective disorder Raloxifene is a Selective Estrogen Receptor Modulator SERM which means that it can affect the central nervous system CNS effects of estrogen eg improving emotional symptoms memory information processing and concentration without adversely affecting reproductive tissueorgans such as breast uterus and ovaries The investigators are conducting a double-blind placebo controlled three month study comparing the psychotic symptom response of women with schizophrenia in both groups One group will receive standard antipsychotic medication plus 120mg Raloxifene while the second group will receive standard antipsychotic medication plus oral placebo
Hypothesis 1 That the women receiving adjunctive Raloxifene would have a quicker recovery from psychotic symptoms as measured on the rating scales compared with the women receiving adjunctive placebo
Hypothesis 2 That the Raloxifene group would have better cognitive improvement than the placebo group
Hypothesis 1 That the women receiving adjunctive Raloxifene would have a quicker recovery from psychotic symptoms as measured on the rating scales compared with the women receiving adjunctive placebo
Hypothesis 2 That the Raloxifene group would have better cognitive improvement than the placebo group
Detailed Description:
Estrogen is hypothesised to be protective for women against early onset of severe symptoms of schizophrenia Hafner 1991 Seeman 1992 This estrogen hypothesis was derived from epidemiological clinical and animal studies Following the results of such studies the investigators conducted a study Kulkarni et al 1996 in which a group of premenopausal women with schizophrenia were given 002mg oral estradiol as an adjunct to antipsychotic drug treatment for eight weeks and compared their progress with a similar group who received antipsychotic drugs only The group receiving estrogen made a significantly more rapid recovery from acute psychotic symptoms and also reported improvement in their general health status Subsequently the investigators conducted a four week double-blind placebo-controlled study using 100mcg estradiol skin patches The investigators found that the 12 premenopausal women who received the estradiol adjunct had a significantly lower total PANSS and BPRS score than 12 women who received placebo patches plus antipsychotic medication
The major potential risks in using estrogen as a longer term adjunctive treatment in premenopausal women with schizophrenia appear to be the potential harmful effects of estrogen itself in its action on breast and uterine tissue Our studies were brief for this reason in that the investigators used estrogen without progesterone over an eight week or four week period
With the recent advent of Selective Estrogen Receptor Modulators in particular Raloxifene Hydrochloride there is the potential to harness the positive estrogenic effect on CNS neurotransmitter systems without affecting breast or uterine tissue While the CNS effects of Raloxifene have not been fully studied its actions are mediated through binding to estrogen receptors and can thereby regulate gene expression that is ligand tissue or gene specific By inference then Raloxifene would be expected to impact on dopamine and serotonin pathways in a similar fashion to conjugated estrogen A study Nickleisen et al 1999 on the effect of Raloxifene on cognition in healthy postmenopausal women found a slight increase in verbal memory performance after one month of high dose treatment while no other differences were found after 12 months of treatment There are no studies in women with cognitive impairment where a treatment effect would be more likely to be apparent Similarly there are no clinical studies to date investigating the effect of Raloxifene on psychotic symptoms To this end the investigators are putting forward an investigator initiated clinical trial proposal to investigate the effect of adjunctive Raloxifene on psychotic symptoms in women with schizophrenia This is therefore a study to follow our Pilot Study in the same area but with an increase of Raloxifene from 60mg to 120mg daily
The aim of this project is to study the effect of Raloxifene as an adjunct to antipsychotic medication in women with schizophrenia as a means to developing a novel safe adjunctive treatment for women with schizophrenia to improve their quality of life
The major potential risks in using estrogen as a longer term adjunctive treatment in premenopausal women with schizophrenia appear to be the potential harmful effects of estrogen itself in its action on breast and uterine tissue Our studies were brief for this reason in that the investigators used estrogen without progesterone over an eight week or four week period
With the recent advent of Selective Estrogen Receptor Modulators in particular Raloxifene Hydrochloride there is the potential to harness the positive estrogenic effect on CNS neurotransmitter systems without affecting breast or uterine tissue While the CNS effects of Raloxifene have not been fully studied its actions are mediated through binding to estrogen receptors and can thereby regulate gene expression that is ligand tissue or gene specific By inference then Raloxifene would be expected to impact on dopamine and serotonin pathways in a similar fashion to conjugated estrogen A study Nickleisen et al 1999 on the effect of Raloxifene on cognition in healthy postmenopausal women found a slight increase in verbal memory performance after one month of high dose treatment while no other differences were found after 12 months of treatment There are no studies in women with cognitive impairment where a treatment effect would be more likely to be apparent Similarly there are no clinical studies to date investigating the effect of Raloxifene on psychotic symptoms To this end the investigators are putting forward an investigator initiated clinical trial proposal to investigate the effect of adjunctive Raloxifene on psychotic symptoms in women with schizophrenia This is therefore a study to follow our Pilot Study in the same area but with an increase of Raloxifene from 60mg to 120mg daily
The aim of this project is to study the effect of Raloxifene as an adjunct to antipsychotic medication in women with schizophrenia as a means to developing a novel safe adjunctive treatment for women with schizophrenia to improve their quality of life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03T-422 | None | None | None |