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

NCT ID: NCT01111565

Last Updated: 2021-12-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 137 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-04
• Study Completion Date: 2011-09-01

Brief 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.

Detailed 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

Conditions

Major Depressive Disorder (MDD)

Keywords

Major Depressive Disorder; MDD; Depression

Study Design

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

Study Groups

Phase B: Single-blind Prospective Treatment Phase

Escitalopram 10 mg capsule, orally, once daily increased to 20 mg/day at the Week 1 (end of Week 1) based upon tolerability profile, for 8 weeks. No dose reductions were allowed after Week 4 and no dose increments were allowed after Week 3. Participants with incomplete response at the end of the Phase B (Week 8) entered Phase C and the rest of the participants continued to Phase B+.

Group Type: EXPERIMENTAL

Escitalopram

Intervention Type: DRUG

Escitalopram capsule administered orally, once daily without regard to meals.

Phase B+: Single-blind Phase B Responders

Participants with response (≥50% reduction in depressive symptom severity in HAM-D17 Total Score; or a HAM-D17 Total Score of \<14 at Week 8 or a Clinical Global Impression of Improvement (CGI-I) Score of \<3 at the Week 6 or 8) at the end of the Phase B (Week 8) continued treatment with the single-blind escitalopram monotherapy at the dose (10 or 20 mg/day) taken during the final week of Phase B, for an additional 6 weeks (Up to Week 14), in Phase B+.

Group Type: EXPERIMENTAL

Escitalopram

Intervention Type: DRUG

Escitalopram capsule administered orally, once daily without regard to meals.

Phase C: Aripiprazole/Escitalopram Combination

Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily in combination with the escitalopram 10 or 20 mg orally for 6 weeks (Up to Week 14), in Phase C. No dose adjustments were allowed for escitalopram during Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated.

Group Type: EXPERIMENTAL

Escitalopram

Intervention Type: DRUG

Escitalopram capsule administered orally, once daily without regard to meals.

Aripiprazole

Intervention Type: DRUG

Aripiprazole capsule administered orally, once daily without regard to meals.

Phase C: Escitalopram Monotherapy

Participants with incomplete response at Week 8 who were randomized to this arm group received escitalopram monotherapy 10 or 20 mg capsule, orally, once daily, whichever dose was taken during the final week of Phase B for 6 weeks (Up to Week 14), in Phase C. No dose adjustments were allowed for escitalopram monotherapy during Phase C.

Group Type: EXPERIMENTAL

Escitalopram

Intervention Type: DRUG

Escitalopram capsule administered orally, once daily without regard to meals.

Phase C: Aripiprazole Monotherapy

Participants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily for 6 weeks (Up to Week 14), in Phase C. Participants were titrated to the aripiprazole target dose of 12 mg/day at Week 9 if the initial 6 mg/day dose was tolerated. No dose increments were allowed after Week 12; however, doses may have been decreased at any visit, based upon tolerability.

Group Type: EXPERIMENTAL

Aripiprazole

Intervention Type: DRUG

Aripiprazole capsule administered orally, once daily without regard to meals.

Interventions

Escitalopram

Escitalopram capsule administered orally, once daily without regard to meals.

Intervention Type: DRUG

Aripiprazole

Aripiprazole capsule administered orally, once daily without regard to meals.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tucson, Arizona, United States

Chino, California, United States

Riverside, California, United States

Torrance, California, United States

Hamden, Connecticut, United States

Marietta, Georgia, United States

Belmont, Massachusetts, United States

Weymouth, Massachusetts, United States

Saint Charles, Missouri, United States

St Louis, Missouri, United States

Brooklyn, New York, United States

Garfield Heights, Ohio, United States

Philadelphia, Pennsylvania, United States

East Providence, Rhode Island, United States

Kirkland, Washington, United States

Penticton, British Columbia, Canada

Vancouver, British Columbia, Canada

Burlington, Ontario, Canada

Osijek, , Croatia

Rijeka, , Croatia

Zagreb, , Croatia

Zagreb, , Croatia

Douai, , France

Élancourt, , France

Baja, , Hungary

Balassagyarmat, , Hungary

Budapest, , Hungary

Budapest, , Hungary

Gyula, , Hungary

Hyderabad, Andhra Pradesh, India

Visakhapatnam, Andhra Pradesh, India

Mumbai, Maharashtra, India

Tampoi, Johor Bahru, Malaysia

Tampoi, Johor Bahru, Malaysia

Kajang, Selangor, Malaysia

Kuala Lumpur, , Malaysia

Bełchatów, , Poland

Bialystok, , Poland

Bialystok, , Poland

Study Site 1

Choroszcz, , Poland

Study Site 2

Choroszcz, , Poland

Sosnowiec, , Poland

Tuszyn, , Poland

Study Site 1

Cape Town, , South Africa

Study Site 2

Cape Town, , South Africa

Durban, , South Africa

Pretoria, , South Africa

Pretoria, , South Africa

Pretoria, , South Africa

Barcelona, , Spain

Salamanca, , Spain

Gothenburg, , Sweden

Malmo, , Sweden

Countries

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

Other Identifiers

2010-018859-97

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

31-08-263

Identifier Type: -

Identifier Source: org_study_id