Study Stopped
The study was terminated early due to Sponsor decision, closure of this combination therapy program is unrelated to any safety issues, no signals of concern.
Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)
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
2 other identifiers
interventional
237
7 countries
60
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2010
Shorter than P25 for phase_3
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2010
CompletedFirst Posted
Study publicly available on registry
April 27, 2010
CompletedStudy Start
First participant enrolled
July 29, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 27, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 27, 2011
CompletedResults Posted
Study results publicly available
October 26, 2021
CompletedOctober 26, 2021
September 1, 2021
1.2 years
April 22, 2010
September 29, 2021
September 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 from Week 8 indicates improvement. Last observation carried forward (LOCF) method was used for analyses.
Week 8 to Week 14
Secondary Outcomes (2)
Phase C: Clinical Global Impression - Improvement Scale (CGI-I) Score at The End of Phase C (Week 14)
Week 14
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)
Week 8 to Week 14
Study Arms (5)
Phase B: Single-blind Prospective Treatment Phase
ACTIVE COMPARATOREscitalopram 10 mg capsule, orally, once daily increased to 20 mg/day at the end of Week 1 based upon tolerability profile, plus one matching placebo capsule, 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+.
Phase B+: Single-blind Phase B Responders
ACTIVE COMPARATORParticipants with response 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 plus one matching placebo capsule, for an additional 6 weeks, in Phase B+.
Phase C: Escitalopram Monotherapy
ACTIVE COMPARATORParticipants 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 plus one matching placebo capsule for 6 weeks, in Phase C. No dose adjustments were allowed for escitalopram monotherapy during Phase C.
Phase C: Aripiprazole Monotherapy
ACTIVE COMPARATORParticipants with incomplete response at Week 8 who were randomized to this arm group received aripiprazole 3, 6, or 12 mg capsule, orally, once daily plus one matching placebo capsule for 6 weeks, 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 week, based upon tolerability.
Phase C: Aripiprazole/Escitalopram Combination Therapy
ACTIVE COMPARATORParticipants 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, once daily plus one matching placebo capsule for 6 weeks, 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.
Interventions
Escitalopram oral capsules.
Aripiprazole oral capsules.
Study drug matching placebo capsule.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (60)
Unknown Facility
Birmingham, Alabama, 35216, United States
Unknown Facility
Little Rock, Arkansas, 72223, United States
Unknown Facility
Carson, California, 90746, United States
Unknown Facility
Garden Grove, California, 95231, United States
Unknown Facility
Imperial, California, 92251, United States
Unknown Facility
Mission Viejo, California, 92691, United States
Unknown Facility
Redlands, California, 92374, United States
Unknown Facility
San Diego, California, 92128, United States
Unknown Facility
Atlanta, Georgia, 30308, United States
Unknown Facility
Atlanta, Georgia, 30328, United States
Unknown Facility
Hoffman Estates, Illinois, 60169, United States
Unknown Facility
Terre Haute, Indiana, 47802, United States
Unknown Facility
Overland Park, Kansas, 66211, United States
Unknown Facility
Prairie Village, Kansas, 66206, United States
Unknown Facility
Wichita, Kansas, 67207, United States
Unknown Facility
Baltimore, Maryland, 21204, United States
Unknown Facility
New York, New York, 10021, United States
Unknown Facility
Toledo, Ohio, 43623, United States
Unknown Facility
Bartlett, Tennessee, 38134, United States
Unknown Facility
Wichita Falls, Texas, 76309, United States
Unknown Facility
Brisbane, Queensland, 4000, Australia
Unknown Facility
Everton Park, Queensland, 4053, Australia
Unknown Facility
Malvern, Victoria, 3144, Australia
Unknown Facility
Melbourne, Victoria, 3004, Australia
Unknown Facility
Fremantle, Western Australia, 6959, Australia
Unknown Facility
Burgas, 8000, Bulgaria
Unknown Facility
Lovech, 5500, Bulgaria
Unknown Facility
Novi Iskar, 1282, Bulgaria
Unknown Facility
Pleven, 5800, Bulgaria
Unknown Facility
Plovdiv, 4000, Bulgaria
Unknown Facility
Rousse, 7003, Bulgaria
Unknown Facility
Sofia, 1113, Bulgaria
Unknown Facility
Sofia, 1431, Bulgaria
Unknown Facility
Sofia, 1606, Bulgaria
Unknown Facility
Tsarev Brod, 9747, Bulgaria
Unknown Facility
Tserova Koria, 5047, Bulgaria
Unknown Facility
Varna, 9000, Bulgaria
Unknown Facility
Tirupati, Andhra Pradesh, 517507, India
Unknown Facility
Vijayawada, Andhra Pradesh, 500072, India
Unknown Facility
Manipal, Karnataka, 576104, India
Unknown Facility
Pune, Maharashtra, 411004, India
Unknown Facility
Ludhiana, Punjab, 141001, India
Unknown Facility
Chennai, Tamil Nadu, 600003, India
Unknown Facility
Kanpur, Uttar Pradesh, 208005, India
Unknown Facility
Quezon City, NCR, 1101, Philippines
Unknown Facility
Quezon City, NCR, 1102, Philippines
Unknown Facility
Bucharest, 010825, Romania
Unknown Facility
Bucharest, 030455, Romania
Study Site 1
Bucharest, 041914, Romania
Study Site 2
Bucharest, 041914, Romania
Unknown Facility
Craiova, 200620, Romania
Unknown Facility
Craiova, 540139, Romania
Unknown Facility
Iași, 700282, Romania
Unknown Facility
Târgovişte, 130081, Romania
Unknown Facility
Târgu Mureş, 540139, Romania
Unknown Facility
Michalovce, 07101, Slovakia
Unknown Facility
Rimavská Sobota, 97901, Slovakia
Unknown Facility
Svidník, 8901, Slovakia
Unknown Facility
Trenčín, 91101, Slovakia
Unknown Facility
Zlaté Moravce, 95301, Slovakia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated early due to Sponsor decision, closure of this combination therapy program is unrelated to any safety issues, no signals of concern.
Results Point of Contact
- Title
- Global Clinical Development
- Organization
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2010
First Posted
April 27, 2010
Study Start
July 29, 2010
Primary Completion
September 27, 2011
Study Completion
September 27, 2011
Last Updated
October 26, 2021
Results First Posted
October 26, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
- Access Criteria
- Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.