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Clinical Trials/NCT00725270
NCT00725270TerminatedPhase 2

Treatment of Schizoaffective Disorder Using Mifepristone

Stanford University1 site in 1 country12 target enrollmentStarted: April 1998Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Terminated
Enrollment
12
Locations
1
Primary Endpoint
Change in Mood Symptoms

Study Overview

Brief Summary

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

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • The subjects will be 30 inpatients or outpatients with schizoaffective disorder.

Exclusion Criteria

  • Subjects must be between the ages of eighteen and seventy-five without major medical problems.

Arms & Interventions

Placebo

Placebo Comparator

Patients will be randomized to placebo

Intervention: Placebo Oral Tablet (Drug)

Mifepristone

Experimental

Patients will be randomized to mifepristone

Intervention: Mifepristone (Drug)

Outcomes

Primary Outcomes

Change in Mood Symptoms

Time Frame: Baseline and Day 9

Utilized the Hamilton Depression Rating Scale, 21-item version to assess depressive symptoms, with a range of 0-63, with higher scores indicating greater levels of depression.

Change in Positive Psychotic Symptoms Over the Course of Treatment

Time Frame: 8 days

Utilized the Positive Symptoms Subscale of the Brief Psychiatric Rating Scale is assess psychotic symptoms. Range for the subscale is 4-28, with 4 = no positive symptoms

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jennifer Keller

Principle Investigator

Stanford University

Study Sites (1)

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