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Treatment of Schizoaffective Disorder Using Mifepristone

NCT ID: NCT00725270

Last Updated: 2017-03-24

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-04-30

Study Completion Date

2009-05-31

Brief Summary

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This study tests the hypothesis that mifepristone will diminish cognitive distortion and alleviate psychosis in patients with schizoaffective disorder.

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Detailed Description

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You are invited to participate in a research study which evaluates the effectiveness of mifepristone (RU 486) in rapidly reducing the symptoms associated with schizoaffective disorder. Our group believes that the cognitive deficits (a decline in the ability to think clearly) and psychosis (hallucinations or delusions) exhibited in some affective disorders are driven by an excess of stress hormone effects (hypercortisolemia). Often the origin of this hormonal imbalance is unknown. Current treatment for schizoaffective disorder (characterized by mood swings and hallucinations and/or delusions) involves using a combination of antidepressant medication (for mood elevation), mood stabilizing medications (to prevent extreme high and low moods) and antipsychotic medication (for the correction of altered thinking). While these therapies are often effective, they can take several weeks or longer to work. We hope to uncover a quick, effective, safe therapy for the treatment of individuals with your condition.

Conditions

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Psychotic Disorders Depressive Disorder, Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Patients will be randomized to placebo

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Placebo comparator

Mifepristone

Patients will be randomized to mifepristone

Group Type EXPERIMENTAL

Mifepristone

Intervention Type DRUG

600 mg of mifepristone

Interventions

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Mifepristone

600 mg of mifepristone

Intervention Type DRUG

Placebo Oral Tablet

Placebo comparator

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria:The subjects will be 30 inpatients or outpatients with schizoaffective disorder.

Exclusion Criteria

Exclusion Criteria:Subjects must be between the ages of eighteen and seventy-five without major medical problems.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pritzker Family Foundation

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Keller

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer Keller

Role: STUDY_DIRECTOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

References

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Cherian K, Schatzberg AF, Keller J. HPA axis in psychotic major depression and schizophrenia spectrum disorders: Cortisol, clinical symptomatology, and cognition. Schizophr Res. 2019 Nov;213:72-79. doi: 10.1016/j.schres.2019.07.003. Epub 2019 Jul 12.

Reference Type DERIVED
PMID: 31307859 (View on PubMed)

Other Identifiers

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76458

Identifier Type: -

Identifier Source: secondary_id

SU-06012008-1191

Identifier Type: -

Identifier Source: org_study_id

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