Major Depression With Psychotic Features
Conditions
Keywords
depression
Brief summary
The purpose of this study is to determine the safety and efficacy of risperidone monotherapy in the treatment of psychotic depression. We hypothesize that risperidone is as equally as effective as haloperidol plus sertraline for depression with psychotic features
Detailed description
Risperidone is a novel antipsychotic that is usually not associated with the adverse effects of neuroleptics. In addition, preliminary evidence suggests that it has additional mood stabilizing properties as compared with neuroleptics. We are examining the effect of risperidone alone for the treatment of psychotic depression. After providing written informed consent, subjects with major depression and psychosis will undergo a routine medical and neurological evaluation. If subjects qualify they will undergo a 3 to 7 day washout. Subjects will be randomly assigned under double-blind conditions to risperidone plus placebo; risperidone plus sertraline; or haloperidol (HPDL) plus sertraline in a prospective parallel design for a 6 week trial. Outcome measures include the Hamilton Rating Depression Scale, The Positive and Negative Symptom Scale and the Clinician Administered Ratings Scale for Mania and Simpson Angus Scale. Rating will be conducted on a weekly basis throughout the study.
Interventions
DRUGrisperidone
Sponsors
Janssen, LP
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Subjects will be men and women 18 to 70 years of age with major depression and psychosis that is either an initial episode or a recurrent episode (unipolar or bipolar). * Subjects with an anxiety disorder or an additional mood disorder such as dysthymia are eligible. * Baseline HDRS score of greater than 21. * A baseline PANSS score of greater than 4 on at least one of the 5 psychosis items
Exclusion criteria
* Pregnant women Women of child-bearing age who refuse a urine pregnancy test or who refuse to use a contraceptive technique when sexually active. * Persons with other psychotic disorders; a mood disorder due to a general medical condition or substance-induced; a current substance dependence disorder; or a dementing disorder are excluded. * Persons with serious, unstable medical illnesses.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Positive and Negative Symptom Scale | — |
Countries
United States
Outcome results
None listed