Clinical trial NCT01111565: 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: 137
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 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

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: Clinical Global Impression - Improvement Scale (CGI-I) Score at the End of Phase C
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: Tucson
country: United States
state: Arizona
city: Chino
country: United States
state: California
city: Riverside
country: United States
state: California
city: Torrance
country: United States
state: California
city: Hamden
country: United States
state: Connecticut
city: Marietta
country: United States
state: Georgia
city: Belmont
country: United States
state: Massachusetts
city: Weymouth
country: United States
state: Massachusetts
city: Saint Charles
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Brooklyn
country: United States
state: New York
city: Garfield Heights
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: East Providence
country: United States
state: Rhode Island
city: Kirkland
country: United States
state: Washington
city: Penticton
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Burlington
country: Canada
state: Ontario
city: Osijek
country: Croatia
city: Rijeka
country: Croatia
city: Zagreb
country: Croatia
city: Zagreb
country: Croatia
city: Douai
country: France
city: Elancourt
country: France
city: Baja
country: Hungary
city: Balassagyarmat
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Gyula
country: Hungary
city: Hyderabad
country: India
state: Andhra Pradesh
city: Visakhapatnam
country: India
state: Andhra Pradesh
city: Mumbai
country: India
state: Maharashtra
city: Tampoi
country: Malaysia
state: Johor Bahru
city: Tampoi
country: Malaysia
state: Johor Bahru
city: Kajang
country: Malaysia
state: Selangor
city: Kuala Lumpur
country: Malaysia
city: Belchatow
country: Poland
city: Bialystok
country: Poland
city: Bialystok
country: Poland
city: Choroszcz
country: Poland
facility: Study Site 1
city: Choroszcz
country: Poland
facility: Study Site 2
city: Sosnowiec
country: Poland
city: Tuszyn
country: Poland
city: Cape Town
country: South Africa
facility: Study Site 1
city: Cape Town
country: South Africa
facility: Study Site 2
city: Durban
country: South Africa
city: Pretoria
country: South Africa
city: Pretoria
country: South Africa
city: Pretoria
country: South Africa
city: Barcelona
country: Spain
city: Salamanca
country: Spain
city: Göteborg
country: Sweden
city: Malmö
country: Sweden
Study officials:
References: