Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)

Major Depressive Disorder (MDD) Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Patients With Major Depressive Disorder

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01111565
• Other study ID #: 31-08-263
• Secondary ID: 2010-018859-97
• Status: Terminated
• Phase: Phase 3
• Start date: October 4, 2010
• Est. completion date: September 1, 2011

Study information

• Verified date: December 2021
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This will be a multicenter, randomized, double-blind study designed to assess the efficacy, safety and tolerability of an oral Aripiprazole/Escitalopram combination therapy in participants with MDD who have demonstrated an incomplete response to a prospective trial of Escitalopram, and report a treatment history for the current MDD episode of an inadequate response to at least one and no more than three adequate trials of an approved antidepressant other than Escitalopram. An inadequate response is defined as less than a 50% reduction in depressive symptom severity as assessed by the participant's self-report on the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (ATRQ) and evaluated by the investigator as part of the participant's medical and psychiatric history. An adequate trial is defined as an antidepressant treatment for at least 6 weeks duration (or at least 3 weeks for combination treatments) at an approved dose as specified in the ATRQ.

Description:

The study will be organized as follows:

• Screening Phase

• Single-blind Prospective Treatment Phase

• Single-blind Continuation Phase (Responder)or Double-blind Randomization Phase (non-Responder)

• 30 day Post Treatment Follow-up

Assigned Interventions:

• Escitalopram monotherapy

• Aripiprazole/Escitalopram combination therapy

• Aripiprazole monotherapy

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 137
• Est. completion date: September 1, 2011
• Est. primary completion date: September 1, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Participants with a current diagnosis of a major depressive episode. The current depressive episode must be =8 weeks in duration

• Participants willing to discontinue all prohibited psychotropic medication starting from the time of signing the informed consent and during the study period

• Participants with a 17-item Hamilton Depression Rating Scale (HAM-D17) Total Score =18 at the Baseline for the Prospective Treatment Phase

Exclusion Criteria:

• Lack of prior treatment with an antidepressant during the current depressive episode

• Participants who report treatment with adjunctive or monotherapy antipsychotic treatment during the current depressive episode.

• Participants experiencing hallucinations, delusions or any psychotic symptomatology in the current depressive episode

• Participants with epilepsy or significant history of seizure disorders

• Participants with a clinically significant current diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder

• Participants who have received electroconvulsive therapy (ECT) in the last 10 years

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder (MDD)

Intervention

Drug:
• Escitalopram
Escitalopram capsule administered orally, once daily without regard to meals.
• Aripiprazole
Aripiprazole capsule administered orally, once daily without regard to meals.

Locations

Country	Name	City	State
Poland	Study Site 1	Choroszcz
Poland	Study Site 2	Choroszcz
South Africa	Study Site 1	Cape Town
South Africa	Study Site 2	Cape Town

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Croatia,  France,  Hungary,  India,  Malaysia,  Poland,  South Africa,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase C: Mean Change From End of Phase B (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to End of Phase C (Week 14)	The MADRS assessed severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms). Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. Last observation carried forward (LOCF) method was used for analyses.	Week 8 to Week 14
Secondary	Phase C: Clinical Global Impression - Improvement Scale (CGI-I) Score at the End of Phase C	CGI-I is a 7-point clinician-rated scale ranging from 1 to 7, rated as 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. A higher score indicates greater impairment. LOCF method was used for analyses.	Week 14
Secondary	Phase C: Mean Change From End of Phase B (Week 8) in the Sheehan Disability Scale (SDS) Mean Score to End of Phase C (Week 14)	SDS is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. The participant is asked to rate the degree to which their functioning is impaired on an 11-point scale, ranging from 0 (not at all) to 10 (extremely). Scores of 0 to 3 indicate mild functional impairment, 4 to 6 indicate moderate functional impairment, and 7 to 9 indicate marked functional impairment. The scores for the 3 domains are summed into a total score that ranges from 0 (unimpaired) to 30 (highly impaired). A higher score indicates greater impairment. A negative change score indicates improvement. LOCF method was used for analyses.	Week 8 to Week 14