Clinical trial NCT01111552: 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: 237
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 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: Clinical Global Impression - Improvement Scale (CGI-I) 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: Birmingham
country: United States
state: Alabama
city: Little Rock
country: United States
state: Arkansas
city: Carson
country: United States
state: California
city: Garden Grove
country: United States
state: California
city: Imperial
country: United States
state: California
city: Mission Viejo
country: United States
state: California
city: Redlands
country: United States
state: California
city: San Diego
country: United States
state: California
city: Atlanta
country: United States
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Hoffman Estates
country: United States
state: Illinois
city: Terre Haute
country: United States
state: Indiana
city: Overland Park
country: United States
state: Kansas
city: Prairie Village
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Baltimore
country: United States
state: Maryland
city: New York
country: United States
state: New York
city: Toledo
country: United States
state: Ohio
city: Bartlett
country: United States
state: Tennessee
city: Wichita Falls
country: United States
state: Texas
city: Brisbane
country: Australia
state: Queensland
city: Everton Park
country: Australia
state: Queensland
city: Malvern
country: Australia
state: Victoria
city: Melbourne
country: Australia
state: Victoria
city: Fremantle
country: Australia
state: Western Australia
city: Bourgas
country: Bulgaria
city: Lovech
country: Bulgaria
city: Novi Iskar
country: Bulgaria
city: Pleven
country: Bulgaria
city: Plovdiv
country: Bulgaria
city: Rousse
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Tsarev Brod
country: Bulgaria
city: Tserova Koria
country: Bulgaria
city: Varna
country: Bulgaria
city: Tirupati
country: India
state: Andhra Pradesh
city: Vijayawada
country: India
state: Andhra Pradesh
city: Manipala
country: India
state: Karnataka
city: Pune
country: India
state: Maharashtra
city: Ludhiana
country: India
state: Punjab
city: Chennai
country: India
state: Tamil Nadu
city: Kanpur
country: India
state: Uttar Pradesh
city: Quezon City
country: Philippines
state: NCR
city: Quezon City
country: Philippines
state: NCR
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
city: Bucuresti
country: Romania
facility: Study Site 1
city: Bucuresti
country: Romania
facility: Study Site 2
city: Craiova
country: Romania
city: Craiova
country: Romania
city: Iasi
country: Romania
city: Targoviste
country: Romania
city: Targu Mures
country: Romania
city: Michalovce
country: Slovakia
city: Rimavska Sobota
country: Slovakia
city: Svidnik
country: Slovakia
city: Trencin
country: Slovakia
city: Zlate Moravce
country: Slovakia
Study officials:
References: