Depressive Disorder, Depressive Disorder, Major, Psychotic Disorders
Conditions
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.
Interventions
DRUGMifepristone
600 mg of mifepristone
DRUGPlacebo Oral Tablet
Placebo comparator
Sponsors
Pritzker Family Foundation
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Positive Psychotic Symptoms Over the Course of Treatment | 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 |
| Change in Mood Symptoms | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Patients will be randomized to placebo | 5 |
| Mifepristone Patients will be randomized to mifepristone | 7 |
| Total | 12 |
Baseline characteristics
| Characteristic | Placebo | Total | Mifepristone |
|---|---|---|---|
| Age, Continuous | 36.4 years STANDARD_DEVIATION 15.9 | 31.08 years STANDARD_DEVIATION 12.4 | 27.29 years STANDARD_DEVIATION 8.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 9 Participants | 7 Participants |
| Region of Enrollment United States | 5 Participants | 12 Participants | 7 Participants |
| Sex: Female, Male Female | 1 Participants | 6 Participants | 5 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 5 | 0 / 7 |
| serious Total, serious adverse events | 0 / 5 | 0 / 7 |
Outcome results
Primary
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.
Time frame: Baseline and Day 9
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in Mood Symptoms | Baseline | 26.2 units on a scale | Standard Deviation 10.3 |
| Placebo | Change in Mood Symptoms | Day 9 | 19.0 units on a scale | Standard Deviation 8.3 |
| Mifepristone | Change in Mood Symptoms | Baseline | 24.86 units on a scale | Standard Deviation 4 |
| Mifepristone | Change in Mood Symptoms | Day 9 | 13.57 units on a scale | Standard Deviation 5.5 |
p-value: 0.203Mixed Models Analysis
Primary
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
Time frame: 8 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in Positive Psychotic Symptoms Over the Course of Treatment | Baseline PSS Scores | 12.0 units on a scale | Standard Deviation 5.2 |
| Placebo | Change in Positive Psychotic Symptoms Over the Course of Treatment | Day 9 PSS scores | 11.0 units on a scale | Standard Deviation 6.4 |
| Mifepristone | Change in Positive Psychotic Symptoms Over the Course of Treatment | Baseline PSS Scores | 7.57 units on a scale | Standard Deviation 3.5 |
| Mifepristone | Change in Positive Psychotic Symptoms Over the Course of Treatment | Day 9 PSS scores | 6.0 units on a scale | Standard Deviation 4.4 |
Comparison: Repeated Measures ANOVA was run on the Positive Symptom Scale of the Brief Psychiatric Rating Scale, using Baseline and Day 9 ratings. Below is the medication \* time interaction.p-value: 0.812Mixed Models Analysis