Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)
NCT ID: NCT01111552
Last Updated: 2021-10-26
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE3
237 participants
INTERVENTIONAL
2010-07-29
2011-09-27
Brief Summary
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Phase B: Single-blind Prospective Treatment Phase
Escitalopram 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+.
Escitalopram
Escitalopram oral capsules.
Placebo
Study drug matching placebo capsule.
Phase B+: Single-blind Phase B Responders
Participants 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+.
Escitalopram
Escitalopram oral capsules.
Placebo
Study drug matching placebo capsule.
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 plus one matching placebo capsule for 6 weeks, in Phase C. No dose adjustments were allowed for escitalopram monotherapy during Phase C.
Escitalopram
Escitalopram oral capsules.
Placebo
Study drug matching placebo capsule.
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 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.
Aripiprazole
Aripiprazole oral capsules.
Placebo
Study drug matching placebo capsule.
Phase C: Aripiprazole/Escitalopram Combination Therapy
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, 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.
Escitalopram
Escitalopram oral capsules.
Aripiprazole
Aripiprazole oral capsules.
Placebo
Study drug matching placebo capsule.
Interventions
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Escitalopram
Escitalopram oral capsules.
Aripiprazole
Aripiprazole oral capsules.
Placebo
Study drug matching placebo capsule.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Locations
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Birmingham, Alabama, United States
Little Rock, Arkansas, United States
Carson, California, United States
Garden Grove, California, United States
Imperial, California, United States
Mission Viejo, California, United States
Redlands, California, United States
San Diego, California, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Hoffman Estates, Illinois, United States
Terre Haute, Indiana, United States
Overland Park, Kansas, United States
Prairie Village, Kansas, United States
Wichita, Kansas, United States
Baltimore, Maryland, United States
New York, New York, United States
Toledo, Ohio, United States
Bartlett, Tennessee, United States
Wichita Falls, Texas, United States
Brisbane, Queensland, Australia
Everton Park, Queensland, Australia
Malvern, Victoria, Australia
Melbourne, Victoria, Australia
Fremantle, Western Australia, Australia
Burgas, , Bulgaria
Lovech, , Bulgaria
Novi Iskar, , Bulgaria
Pleven, , Bulgaria
Plovdiv, , Bulgaria
Rousse, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Tsarev Brod, , Bulgaria
Tserova Koria, , Bulgaria
Varna, , Bulgaria
Tirupati, Andhra Pradesh, India
Vijayawada, Andhra Pradesh, India
Manipal, Karnataka, India
Pune, Maharashtra, India
Ludhiana, Punjab, India
Chennai, Tamil Nadu, India
Kanpur, Uttar Pradesh, India
Quezon City, NCR, Philippines
Quezon City, NCR, Philippines
Bucharest, , Romania
Bucharest, , Romania
Study Site 1
Bucharest, , Romania
Study Site 2
Bucharest, , Romania
Craiova, , Romania
Craiova, , Romania
Iași, , Romania
Târgovişte, , Romania
Târgu Mureş, , Romania
Michalovce, , Slovakia
Rimavská Sobota, , Slovakia
Svidník, , Slovakia
Trenčín, , Slovakia
Zlaté Moravce, , Slovakia
Countries
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Other Identifiers
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2010-018858-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
31-08-256
Identifier Type: -
Identifier Source: org_study_id