Study Stopped
Lack of funding.
Treatment of Schizoaffective Disorder Using Mifepristone
2 other identifiers
interventional
12
1 country
1
Brief Summary
This study tests the hypothesis that mifepristone will diminish cognitive distortion and alleviate psychosis in patients with schizoaffective disorder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 1998
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 1998
CompletedFirst Submitted
Initial submission to the registry
July 28, 2008
CompletedFirst Posted
Study publicly available on registry
July 30, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedResults Posted
Study results publicly available
March 24, 2017
CompletedMarch 24, 2017
February 1, 2017
11.1 years
July 28, 2008
October 11, 2016
February 1, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Change in Positive Psychotic Symptoms Over the Course of Treatment
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
8 days
Change in Mood Symptoms
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.
Baseline and Day 9
Study Arms (2)
Placebo
PLACEBO COMPARATORPatients will be randomized to placebo
Mifepristone
EXPERIMENTALPatients will be randomized to mifepristone
Interventions
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- Pritzker Family Foundationcollaborator
Study Sites (1)
Stanford University School of Medicine
Stanford, California, 94305, United States
Related Publications (1)
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.
PMID: 31307859DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alan Schatzberg
- Organization
- Stanford University
Study Officials
- STUDY DIRECTOR
Jennifer Keller
Stanford University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
July 28, 2008
First Posted
July 30, 2008
Study Start
April 1, 1998
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
March 24, 2017
Results First Posted
March 24, 2017
Record last verified: 2017-02