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Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Patients With Major Depressive Disorder (MDD) (ACES 256)

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ClinicalTrials.gov Identifier: NCT01111552
Recruitment Status : Terminated
First Posted : April 27, 2010
Last Update Posted : August 31, 2012
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

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 subjects 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 subject's self-report on the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (ATRQ) and evaluated by the investigator as part of the subject'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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder (MDD) Drug: Escitalopram Drug: Aripiprazole Drug: Aripiprazole/Escitalopram combination Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : July 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Escitalopram monotherapy Drug: Escitalopram
Escitalopram monotherapy

Active Comparator: Aripiprazole monotherapy Drug: Aripiprazole
Aripiprazole monotherapy

Active Comparator: Aripiprazole/Escitalopram combination therapy Drug: Aripiprazole/Escitalopram combination
Aripiprazole/Escitalopram combination therapy




Primary Outcome Measures :
  1. Mean change in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: from Week 8 to Week 14 ]
    The primary efficacy endpoint is the mean change from the end of Week 8 Visit to the end of Week 14 Visit in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with a current diagnosis of a major depressive episode. The current depressive episode must be ≥ 8 weeks in duration
  • Subjects willing to discontinue all prohibited psychotropic medication starting from the time of signing the informed consent and during the study period
  • Subjects with a 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
  • Subjects who report treatment with adjunctive or monotherapy antipsychotic treatment during the current depressive episode.
  • Subjects experiencing hallucinations, delusions or any psychotic symptomatology in the current depressive episode
  • Subjects with epilepsy or significant history of seizure disorders
  • Subjects with a clinically significant current diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder
  • Subjects who have received electroconvulsive therapy (ECT) in the last 10 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01111552


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Locations
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United States, Alabama
Birmingham, Alabama, United States, 35216
United States, Arkansas
Little Rock, Arkansas, United States, 72223
United States, California
Carson, California, United States, 90746
Garden Grove, California, United States, 95231
Imperial, California, United States, 92251
Mission Viejo, California, United States, 92691
Redlands, California, United States, 92374
San Diego, California, United States, 92128
United States, Georgia
Atlanta, Georgia, United States, 30308
Atlanta, Georgia, United States, 30328
United States, Illinois
Hoffman Estates, Illinois, United States, 60169
United States, Indiana
Terre Haute, Indiana, United States, 47802
United States, Kansas
Overland Park, Kansas, United States, 66211
Prairie Village, Kansas, United States, 66206
Wichita, Kansas, United States, 67207
United States, Maryland
Baltimore, Maryland, United States, 21204
United States, New York
New York, New York, United States, 10021
United States, Ohio
Toledo, Ohio, United States, 43623
United States, Tennessee
Bartlett, Tennessee, United States, 38134
United States, Texas
Wichita Falls, Texas, United States, 76309
Australia, Queensland
Brisbane, Queensland, Australia, 4000
Everton Park, Queensland, Australia, 4053
Australia, Victoria
Malvern, Victoria, Australia, 3144
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
Fremantle, Western Australia, Australia, 6959
Bulgaria
Bourgas, Bulgaria, 8000
Lovech, Bulgaria, 5500
Novi Iskar, Bulgaria, 1282
Pleven, Bulgaria, 5800
Plovdiv, Bulgaria, 4000
Rousse, Bulgaria, 7003
Sofia, Bulgaria, 1113
Sofia, Bulgaria, 1431
Sofia, Bulgaria, 1606
Tsarev Brod, Bulgaria, 9747
Tserova Koriya, Bulgaria, 5047
Varna, Bulgaria, 9000
India
Tirupati, Andhra Pradesh, India, 517507
Vijaywada, Andhra Pradesh, India, 500072
Manipal, Karnataka, India, 576104
Pune, Maharashtra, India, 411004
Ludhiana, Punjab, India, 141001
Chennai, Tamil Nadu, India, 600003
Kanpur, Uttar Pradesh, India, 208005
Philippines
Quezon City, NCR, Philippines, 1101
Quezon City, NCR, Philippines, 1102
Romania
Bucuresti, Romania, 010825
Bucuresti, Romania, 030455
Study Site 1
Bucuresti, Romania, 041914
Study Site 2
Bucuresti, Romania, 041914
Craiova, Romania, 200620
Craiova, Romania, 540139
Iasi, Romania, 700282
Targoviste, Romania, 130081
Targu Mures, Romania, 540139
Slovakia
Michalovce, Slovakia, 07101
Rimavska Sobota, Slovakia, 97901
Svidnik, Slovakia, 8901
Trencin, Slovakia, 91101
Zlate Moravce, Slovakia, 95301
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.

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Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01111552     History of Changes
Other Study ID Numbers: 31-08-256
First Posted: April 27, 2010    Key Record Dates
Last Update Posted: August 31, 2012
Last Verified: August 2012
Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Major Depressive Disorder
MDD
Depression
Additional relevant MeSH terms:
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Dexetimide
Citalopram
Muscarinic Antagonists
Cholinergic Antagonists
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Aripiprazole
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics