Clinical trial NCT01111539: Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Major Depressive Disorder (MDD)
Keywords: Major Depressive Disorder
MDD
Depression
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2010-04-27
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 Hamilton Depression Rating Scale (HAM-D17) Total Score ≥18 at the Baseline Visit 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

Primary outcomes:
measure: 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)
timeFrame: Week 8 to Week 14
Secondary outcomes:
measure: Phase C: Mean Clinical Global Impression - Improvement (CGI-I) Scale Score at the End of Phase C (Week 14)
timeFrame: Week 14
measure: 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)
timeFrame: Week 8 to Week 14
Other outcomes:
Locations:
city: Cerritos
country: United States
state: California
city: Costa Mesa
country: United States
state: California
city: Irvine
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Cromwell
country: United States
state: Connecticut
city: Hartford
country: United States
state: Connecticut
city: Fort Walton Beach
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Libertyville
country: United States
state: Illinois
city: Boston
country: United States
state: Massachusetts
city: Fall River
country: United States
state: Massachusetts
city: Albuquerque
country: United States
state: New Mexico
city: Bronx
country: United States
state: New York
city: Fresh Meadows
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Cary
country: United States
state: North Carolina
city: Oklahoma City
country: United States
state: Oklahoma
city: Memphis
country: United States
state: Tennessee
city: DeSoto
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Brown Deer
country: United States
state: Wisconsin
city: Jamejala
country: Estonia
city: Tallinn
country: Estonia
city: Tartu
country: Estonia
city: Tartu
country: Estonia
city: Helsinki
country: Finland
city: Helsinki
country: Finland
city: Kuopio
country: Finland
city: Oulu
country: Finland
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Munich
country: Germany
city: Ostfildern
country: Germany
city: Ahmedabad
country: India
facility: Study Site 1
state: Gujarat
city: Ahmedabad
country: India
facility: Study Site 2
state: Gujarat
city: Mangalore
country: India
state: Karnataka
city: Mumbai
country: India
state: Maharashtra
city: Pune
country: India
state: Maharashtra
city: Varanasi
country: India
state: Uttar Pradesh
city: Catania
country: Italy
city: Siena
country: Italy
city: Gwangju
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Mexico
country: Mexico
state: DF
city: Tlalnepantla de Baz
country: Mexico
state: Estado Do Mexico
city: Zapopan
country: Mexico
state: Jalisco
city: Monterrey
country: Mexico
state: Nuevo Leon
city: Culiacan
country: Mexico
state: Sinaloa
city: Villahermosa
country: Mexico
state: Tabasco
city: Durango
country: Mexico
city: San Luis Potosi
country: Mexico
city: Changhua
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Keelung
country: Taiwan
city: Taoyuan
country: Taiwan
Study officials:
References: