Risperidone and Suicidality in Major Depressive Disorder

NCT ID: NCT00167154

Last Updated: 2021-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2008-08-31

Brief Summary

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.

Detailed Description

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

risperidone

risperidone

Group Type: EXPERIMENTAL

Risperidone and placebo comparator

Intervention Type: DRUG

Up to 2 mg risperidone or matching placebo daily

placebo

placebo comparator

Group Type: PLACEBO_COMPARATOR

Risperidone and placebo comparator

Intervention Type: DRUG

Up to 2 mg risperidone or matching placebo daily

Interventions

Risperidone and placebo comparator

Up to 2 mg risperidone or matching placebo daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 19-60 years of age

2. Diagnosis of major depressive disorder, currently severe with suicidality

3. A total score of Montgomery-Asberg Depression Rating Scale (MADRS) =/> 25 with the suicide sub-score =/> 4

4. Currently is taking an antidepressant at a therapeutic dose for longer than 3 weeks

5. In good physical health

Exclusion Criteria

1. Depression without suicidality

2. Presence of major psychiatric conditions other than major depressive disorder, such as bipolar disorder, schizophrenia, or anxiety disorders (except for generalized anxiety disorder)

3. Depressive symptoms induced by alcohol or substance abuse

4. Psychotic features which are predominant at the initial evaluation

5. Unstable major medical illness, such as cardiac disease or diabetes

6. Female subjects who are pregnant, breastfeeding, or, if of child-bearing potential, unwilling to use adequate birth control measures

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Roberta May

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaohua Li, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

References

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):1228-1236. doi: 10.4088/jcp.v69n0805.

Reference Type: RESULT

PMID: 18681749 (View on PubMed)

Other Identifiers

RIS-DED-402

Identifier Type: -

Identifier Source: secondary_id

F030929002

Identifier Type: -

Identifier Source: org_study_id