| September 10, 2005 |
| February 3, 2009 |
| June 2004 |
| April 2007 (final data collection date for primary outcome measure) |
| To investigate the efficacy of risperidone as an adjunct to an antidepressant treatment in the acute management of suicidality during an episode of major depressive disorder |
| To investigate the efficacy of risperidone as an adjunct to an antidepressant treatment in the acute management of suicidality during an episode of major depressive disorder. |
| Complete list of historical versions of study NCT00167154 on ClinicalTrials.gov Archive Site |
- To assess the efficacy of risperidone as an adjunct to an antidepressant for the improvement of other symptoms of severe depression
- To assess the onset of effect, the length of treatment required, and the utilization of a hospital in the treatment of depression with suicidality using risperidone adjunctive to an antidepressant
- To assess the efficacy of risperidone as an adjunct to an antidepressant in the improvement of neurocognitive function in depression
- To assess the safety and tolerance of risperidone in the treatment of depression with suicidality
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- To assess the efficacy of risperidone as an adjunct to an antidepressant for the improvement of other symptoms of severe depression.
- To assess the onset of effect, the length of treatment required, and the utilization of hospital in the treatment of depression with suicidality using risperidone adjunctive to an antidepressant.
- To assess the efficacy of risperidone as an adjunct to an antidepressant in the improvement of neurocognitive function in depression.
- To assess the safety and tolerance of risperidone in the treatment of depression with suicidality.
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| |
| Risperidone and Suicidality in Major Depressive Disorder |
| Efficacy of Risperidone in the Management of Suicidality in Major Depressive Disorder |
The purpose of this trial is to investigate the efficacy of risperidone as an adjunct to an antidepressant treatment in the acute management of suicidality during an episode of major depressive disorder. |
Using a double blind, placebo-controlled design, subjects diagnosed with a current episode of major depressive disorder (defined by DSM-IV criteria and supported by the Mini International Neuropsychiatric Interview), severe with suicidality despite currently taking an antidepressant, will be enrolled in the eight-week study. The treatment will be initiated by randomizing patients to receive risperidone or placebo in addition to the antidepressant that the patient is already taking. The clinical efficacy will be evaluated after 4 days, weekly for 4 weeks, then every other week for 4 weeks with the efficacy measures. During the eight-week study, treatment with risperidone or placebo will continue at the highest effective dosage (up to 2 mg per day). The dose of the antidepressant will not be changed during the study. |
| Phase III |
| Interventional |
| Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Depression |
| Drug: risperidone |
| |
| Reeves H, Batra S, May RS, Zhang R, Dahl DC, Li X. Efficacy of risperidone augmentation to antidepressants in the management of suicidality in major depressive disorder: a randomized, double-blind, placebo-controlled pilot study. J Clin Psychiatry. 2008 Aug;69(8):1228-336. |
| |
| Completed |
| 30 |
| August 2008 |
| April 2007 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- 19-60 years of age
- Diagnosis of major depressive disorder, currently severe with suicidality
- A total score of Montgomery-Asberg Depression Rating Scale (MADRS) =/> 25 with the suicide sub-score =/> 4
- Currently is taking an antidepressant at a therapeutic dose for longer than 3 weeks
- In good physical health
Exclusion Criteria:
- Depression without suicidality
- Presence of major psychiatric conditions other than major depressive disorder, such as bipolar disorder, schizophrenia, or anxiety disorders (except for generalized anxiety disorder)
- Depressive symptoms induced by alcohol or substance abuse
- Psychotic features which are predominant at the initial evaluation
- Unstable major medical illness, such as cardiac disease or diabetes
- Female subjects who are pregnant, breastfeeding, or, if of child-bearing potential, unwilling to use adequate birth control measures
|
| Both |
| 19 Years to 60 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00167154 |
|
| F030929002, RIS-DED-402 |
| University of Alabama at Birmingham |
| Janssen Pharmaceuticals |
| Principal Investigator: |
Xiaohua Li, MD, PhD |
University of Alabama at Birmingham |
|
|
| University of Alabama at Birmingham |
| February 2009 |