Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00556140
Other study ID # 2003-P-000990
Secondary ID
Status Completed
Phase Phase 3
First received November 8, 2007
Last updated July 11, 2012
Start date June 2003
Est. completion date January 2008

Study information

Verified date July 2012
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of the study is to assess the safety and effectiveness of the combination of aripiprazole (Abilify) and selective serotonin reuptake inhibitors (SSRIs) in subjects with psychotic major depression.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date January 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

1. Men and women aged 18-80 years, inclusive.

2. Drug-free outpatients or inpatients meeting DSM-IV criteria for major depression with psychotic features.

3. Inpatients who undergo a 5-7 day washout period of their medication while concurrently beginning one of the approved SSRI's and abilify.

4. HAM-D-24 score > 16.

Exclusion Criteria:

1. Pregnant women and women of child bearing potential not using a medically accepted means of contraception (oral contraceptives are allowed).

2. Women who are breast-feeding.

3. Patients meeting DSM-IV criteria for major depression without psychotic features, or psychosis without major depression at the screen visit.

4. Patients with serious suicidal risk.

5. Patients with a history of seizure disorder; unstable physical disorders (cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic); or any physical disorder judged to significantly affect central nervous system function.

6. Patients meeting criteria for the following DSM-IV diagnoses: organic mental disorders; substance use disorders, including alcohol, active within the last 6 months; bipolar disorder; schizoaffective disorder; or antisocial personality disorder.

7. Patients who are currently taking an antidepressant, antipsychotic, or mood stabilizing drug and who are responding to one or all of these medications. If patients are not responding to these medications, they may go through a washout period of at least one week under the supervision of a study doctor before entering into this study.

8. Patients who are not able to read and understand the consent form, or who are not capable of understanding or giving informed consent to the procedures of the study

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Aripiprazole
Everyone in this study will receive aripiprazole and an antidepressant called a selective serotonin reuptake inhibitor (SSRI). There is only one arm for this study. Aripiprazole is an antipsychotic medication that has been approved by the Food and Drug Administration (FDA) for the treatment of schizophrenia. You will receive aripiprazole (Abilify) and one of the following SSRI antidepressant medications that will be determined by the study doctor and you: sertraline (Zoloft), citalapram (Celexa), or escitalopram (Lexapro). The dose of aripiprazole (Abilify) will be 10 milligrams a day, and the starting doses for the SSRI anti-depressants will be: sertraline (Zoloft) 50 milligrams a day, citalopram (Celexa) 20 milligrams a day, and escitalopram (Lexapro) 10 milligrams a day.

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Massachusetts General Hospital Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Depression and Psychosis Response Rate This response rate refers to the percentage of patients who experienced a 50 percent or greater reduction in symptoms. Specifically, this refers to a 50 percent reduction in Hamilton Depression Rating Scale 17 (HAM-D-17) scores from baseline and no psychotic symptoms as measured by the Structured Clinical Interview for DMS-IV psychosis module. HAM-D-17 scores range from 0-50 with a score of >23 considered severely depressed and <7 to be mildly to not at all depressed. Baseline and 7 weeks No
Secondary Depression and Psychosis Remission Rate This remission rate refers to a Hamilton Depression Rating Scale 17 (HAM-D-17) score of 7 or less and no psychotic symptoms as measured by the Structured Clinical Interview for DMS-IV psychosis module. HAM-D-17 scores range from 0-50 with a score of >23 considered severely depressed and <7 to be mildly to not at all depressed. Baseline and 7 weeks No
See also
  Status Clinical Trial Phase
Completed NCT00751504 - Quetiapine in the Treatment of Psychotic Depression - a Pilot Study Phase 3
Recruiting NCT06005766 - The Efficacy of Metacognitive Skills Training in the Context of Forensic Psychiatric Care N/A
Not yet recruiting NCT05034523 - Voxel Based Morphometry In Patients With Psychotic Versus Non Psychotic Depression
Completed NCT02782442 - Cognitive Training Delivered Remotely to Individuals With Psychosis (ROAM) N/A
Completed NCT01427608 - Sustaining Remission of Psychotic Depression Phase 4
Terminated NCT00637494 - A Study of Mifepristone vs. Placebo in the Treatment of Patients With Major Depression With Psychotic Features Phase 3
Completed NCT00400166 - Recovery Guide Intervention for Recurrent Psychiatric Hospitalization N/A