Major Depressive Disorder (MDD)Phase 3NCT01111552
Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Participants With Major Depressive Disorder (MDD)
A Phase 3 study testing Escitalopram and Aripiprazole in people with Major Depressive Disorder (MDD), run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 60 sites in 7 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- Escitalopram and Aripiprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 237 participants
- Where
- 60 sitesin 7 countries
- Study dates
- 29 Jul 2010to 27 Sep 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
60 sites in 7 countries.
60 sites in 7 countries
United States20 sites
Study site
Atlanta, Georgia, 30308
Study site
Atlanta, Georgia, 30328
Study site
Baltimore, Maryland, 21204
Study site
Bartlett, Tennessee, 38134
Study site
Birmingham, Alabama, 35216
Study site
Carson, California, 90746
Study site
Garden Grove, California, 95231
Study site
Hoffman Estates, Illinois, 60169
Study site
Imperial, California, 92251
Study site
Little Rock, Arkansas, 72223
Study site
Mission Viejo, California, 92691
Study site
New York, New York, 10021
Study site
Overland Park, Kansas, 66211
Study site
Prairie Village, Kansas, 66206
Study site
Redlands, California, 92374
Study site
San Diego, California, 92128
Study site
Terre Haute, Indiana, 47802
Study site
Toledo, Ohio, 43623
Study site
Wichita, Kansas, 67207
Study site
Wichita Falls, Texas, 76309
Bulgaria12 sites
Study site
Burgas, 8000
Study site
Lovech, 5500
Study site
Novi Iskar, 1282
Study site
Pleven, 5800
Study site
Plovdiv, 4000
Study site
Rousse, 7003
Study site
Sofia, 1113
Study site
Sofia, 1431
Study site
Sofia, 1606
Study site
Tsarev Brod, 9747
Study site
Tserova Koria, 5047
Study site
Varna, 9000
Romania9 sites
Study site
Bucharest, 010825
Study site
Bucharest, 030455
Study Site 1
Bucharest, 041914
Study Site 2
Bucharest, 041914
Study site
Craiova, 200620
Study site
Craiova, 540139
Study site
Iași, 700282
Study site
Targoviste, 130081
Study site
Târgu Mureş, 540139
India7 sites
Study site
Chennai, Tamil Nadu, 600003
Study site
Kanpur, Uttar Pradesh, 208005
Study site
Ludhiana, Punjab, 141001
Study site
Manipal, Karnataka, 576104
Study site
Pune, Maharashtra, 411004
Study site
Tirupati, Andhra Pradesh, 517507
Study site
Vijayawada, Andhra Pradesh, 500072
Australia5 sites
Study site
Brisbane, Queensland, 4000
Study site
Everton Park, Queensland, 4053
Study site
Fremantle, Western Australia, 6959
Study site
Malvern, Victoria, 3144
Study site
Melbourne, Victoria, 3004
Slovakia5 sites
Study site
Michalovce, 07101
Study site
Rimavská Sobota, 97901
Study site
Svidník, 8901
Study site
Trenčín, 91101
Study site
Zlaté Moravce, 95301
Philippines2 sites
Study site
Quezon City, NCR, 1101
Study site
Quezon City, NCR, 1102
About this study
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
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.
Read the 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
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- Escitalopram, Aripiprazole, Placebo
- Keywords
- Major Depressive Disorder, MDD, Depression
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
Escitalopram oral capsules.
AripiprazoleDrug
Also called OPC-14597
Aripiprazole oral capsules.
PlaceboDrug
Study drug matching placebo capsule.
| Study group | Role | What they receive |
|---|---|---|
| Phase B: Single-blind Prospective Treatment Phase | Active comparator | 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+. Receives: Drug: Escitalopram; Drug: Placebo |
| Phase B+: Single-blind Phase B Responders | Active comparator | 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+. Receives: Drug: Escitalopram; Drug: Placebo |
| Phase C: Escitalopram Monotherapy | Active comparator | 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. Receives: Drug: Escitalopram; Drug: Placebo |
| Phase C: Aripiprazole Monotherapy | Active comparator | 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. Receives: Drug: Aripiprazole; Drug: Placebo |
| Phase C: Aripiprazole/Escitalopram Combination Therapy | Active comparator | 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. Receives: Drug: Escitalopram; Drug: Aripiprazole; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Last observation carried forward (LOCF) method was used for analyses.
Measured: 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)
The SDS is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0= no impairment to 10= most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe). A negative change from Week 8 indicates improvement. Last observation carried forward (LOCF) method was used for analyses.
Measured: Week 8 to Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2010 (estimated)
- Study start29 Jul 2010
- Primary completion27 Sep 2011
- Study completion27 Sep 2011
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01111552
- Sponsor's protocol ID
- 31-08-256
- Other IDs
- 2010-018858-12
- Status last verified
- Sep 2021
- First submitted
- 22 Apr 2010
- Last updated
- 26 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01111552
- Acronym / sponsor ID
- 31-08-256
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- Major Depressive Disorder, MDD, Depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Jul 2010 (actual)
- Primary completion
- 27 Sep 2011 (actual)
- Study completion
- 27 Sep 2011 (actual)
- First posted
- 27 Apr 2010 (estimated)
- Results
- Posted 26 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Phase B: Single-blind Prospective Treatment Phase | Active comparator | Drug: Escitalopram, Drug: PlaceboEscitalopram 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 comparator | Drug: Escitalopram, Drug: PlaceboParticipants 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 comparator | Drug: Escitalopram, Drug: PlaceboParticipants 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 comparator | Drug: Aripiprazole, Drug: PlaceboParticipants 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 comparator | Drug: Escitalopram, Drug: Aripiprazole, Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EscitalopramEscitalopram oral capsules. | Drug | Phase B+: Single-blind Phase B Responders, Phase B: Single-blind Prospective Treatment Phase, Phase C: Aripiprazole/Escitalopram Combination Therapy, Phase C: Escitalopram Monotherapy |
| AripiprazoleAlso: OPC-14597Aripiprazole oral capsules. | Drug | Phase C: Aripiprazole Monotherapy, Phase C: Aripiprazole/Escitalopram Combination Therapy |
| PlaceboStudy drug matching placebo capsule. | Drug | Phase B+: Single-blind Phase B Responders, Phase B: Single-blind Prospective Treatment Phase, Phase C: Aripiprazole Monotherapy, Phase C: Aripiprazole/Escitalopram Combination Therapy, Phase C: Escitalopram Monotherapy |
Primary outcome
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)
Time frame: Week 8 to 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.
2 secondary outcomes
Phase C: Clinical Global Impression - Improvement Scale (CGI-I) Score at The End of Phase C (Week 14)
Time frame: 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)
Time frame: Week 8 to Week 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
60 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Escitalopram and Aripiprazole in people with Major Depressive Disorder (MDD), run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 60 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States, Bulgaria, Romania, India, Australia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: Week 8 to Week 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021.