Aripiprazole Augmentation Versus Switching to Different Class of Antidepressants in Major Depressive Disorder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Korea University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Korea OIAA
Taiwan Otsuka Pharm. Co., Ltd
Information provided by (Responsible Party):
Chansu Han, MD, PhD, MHS, Korea University
ClinicalTrials.gov Identifier:
NCT01488266
First received: December 4, 2011
Last updated: December 6, 2011
Last verified: December 2011
  Purpose

The objective of this study is to compare the efficacy and safety of aripiprazole as adjunctive therapy versus switching to different class of antidepressants for treating major depressive disorder partially or minimally responsive to ongoing antidepressant treatment.


Condition Intervention
Major Depressive Disorder
Drug: Aripiprazole
Drug: switching to different class of antidepressant

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Aripiprazole Augmentation vs Switching to Different Class of Antidepressants for Patients With MDD Who Are Partially/Minimally Responsive to Current Antidepressants:Randomized, Rater-blinded, Prospective Study

Resource links provided by NLM:


Further study details as provided by Korea University:

Primary Outcome Measures:
  • Change of total score of MADRS [ Time Frame: From baseline to end of treatment ] [ Designated as safety issue: No ]
    MADRS: montgomery Asberg Depression Rating Scale

  • Response rate [ Time Frame: at 2 weeks ] [ Designated as safety issue: No ]
    response rate is defined as a reduction in MADRS total score of at least 50% relative to the beginning of the randomized phase (baseline)


Secondary Outcome Measures:
  • Response rate [ Time Frame: at week 2,4 and 6 ] [ Designated as safety issue: No ]
  • Remission rate [ Time Frame: at week 2,4and 6 ] [ Designated as safety issue: No ]
    remission rate is defined as an absolute MADRS total score of ≤10 at the end of treatment

  • Change of total score of HDRS-17 [ Time Frame: from baseline to end of treatment ] [ Designated as safety issue: No ]
    HDRS-17: Hamilton Depression Rating Scale-17 item

  • Change of total score of CGI-S [ Time Frame: from baseline to end of treatment ] [ Designated as safety issue: No ]
    CGI-S: Clinical Global Impression-Severity Score

  • Change of total score of IFS [ Time Frame: from baseline to end of treatment ] [ Designated as safety issue: No ]
    IFS: Iowa Fatigue Scale

  • Change of total score of SDS [ Time Frame: from baseline to end of treatment ] [ Designated as safety issue: No ]
    SDS: Sheehan Disability Scale

  • Patients' ratio who have have scored 1 or 2 in the score of CGI-Improvement [ Time Frame: at the end of treatment ] [ Designated as safety issue: No ]
    CGI-I: Clinical Global Impression-Improvement Score


Estimated Enrollment: 90
Study Start Date: November 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: aripiprazole augmentation Drug: Aripiprazole
patients who are randomly assigned to adjunctive aripiprazole are treated with a starting dose of 2.5 (or 5) mg/day of aripiprazole, which can be increased weekly in 2.5~5mg/day increments to a maximum dose of 15 mg/day based on assessment of tolerability and clinical response. Doses can be decreased at any visit, based on tolerability; They continue to receive the same fixed-dose of the previously used antidepressant throughout the study period when patient is assigned to aripiprazole augmentation group.
Other Name: abilify
Active Comparator: different class of antidepressant Drug: switching to different class of antidepressant
Patients randomly assigned to switching to different antidepressant have to discontinue the previously used antidepressant and receive different antidepressant within flexible therapeutic doses as indication label information (as based on clinicians' preference and experience). Dose increase is permitted until the first 2 weeks of the study.
Other Names:
  • escitalopram
  • fluoxetine
  • paroxetine
  • sertraline
  • bupropion XL
  • mirtazapine
  • venlafaxine
  • milnacipran
  • duloxetine

Detailed Description:

Most guidelines have suggested that those nonresponders or partial responders should be considered for a switch, combination or augmentation of treatment. Traditional augmentation agents, lithium, triiodothyronine (T3), buspirone, dopamine agonists, and stimulants have been commonly used for this patient population with limited supporting data. Recently, augmentation of atypical antipsychotics with antidepressant therapy has become a more commonly accepted treatment practice. This strategy has proven to be useful for enhancement of antidepressant effect, showing increased remission rates and early treatment effects on core depressive symptoms, and comorbid symptoms as well as antidepressant- mediated side effects (e.g., sexual dysfunction). Although, we have some limited treatment options to treat such patients as described above, it is not clear which treatment option would be best or acceptable for those patients in clinical practice yet.

Among above augmentation agents, aripiprazole is the first drug approved by U.S. FDA. as an augmentation therapy to antidepressants in the treatment of patients with MDD showing imminent efficacy and reliable safety profile through adequately-powered well-designed controlled clinical trials.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who are older than 20 years of age have a diagnosis of MDD without psychotic features, as defined by DSM-IV-TR.
  • Patients have to report an inadequate response to a current antidepressant treatment. Inadequate response to antidepressant is defined as: total score of HDRS-17 is more than 14), despite adequate dose of current antidepressant treatment for at least 6 weeks in the current episode(co-administered with ATRQ)
  • Classification of antidepressants which can be included in the study(list for suggestion): Escitalopram 10~20mg/day, fluoxetine 20~40mg/day,paroxetine controlled release(CR) 25~62.5mg or paroxetine 20~40mg, sertraline 100~150mg,bupropion XL(SR) 150~300mg, mirtazapine 15~45mg,venlafaxine immediate or extended release(IR or ER) 112.5~225mg/day, duloxetine 60mg [same criteria for generic medications as brand drugs]

Exclusion Criteria:

  • Those who are first episode, drug naive MDD subjects
  • Those who have a current Axis I diagnosis of delirium, dementia, amnestic or other cognitive disorder, schizophrenia or other psychotic disorder, bipolar 1 or 2 disorder, eating disorder, obsessive-compulsive disorder, panic disorder, or posttraumatic stress disorder
  • Those who have a clinically significant current Axis 2 diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder
  • Those who experience hallucinations, delusion, or any psychotic symptomatology in the current depressive episode
  • Those who have met DSM-IV-TR criteria for any significant substance use disorder within the past 12 months (except nicotine)
  • Those who have known allergy,hypersensitivity or previous unresponsiveness to aripiprazole or known intolerance to other study medications
  • Those who have had cognitive-behavioral therapy or other psychotherapy, or they have the potential need to be treated with them during the study periods
  • Those who are complicated with serious medical problem, such as severe renal, hepatic dysfunction, cardiovascular, lung, gastrointestinal, endocrine, nervous, infectious disease, or neoblastic, metabolic disease
  • Those who have shown previous unresponsiveness to adequate antidepressant trials more than 2 episodes or with 3 or more antidepressant treatments
  • Those who have chronic liver or renal disease
  • Those who are pregnant or brest-feeding
  • Those who have participated in a clinical trial with aripiprazole or any other investigational product within the past month(include randomized, double-blind, placebo-controlled or open-label study; but chart review,observational study can be enrolled)
  • Those who had a history of thyroid pathology, neuroleptic malignant syndrome, or serotonin syndrome
  • Those who have received adjunctive antipsychotic plus antidepressant for more than 3 weeks during the current episode
  • Those who have received electroconvulsive therapy for the current episode
  • Those who have shown an inadequate response to previous ECT in any episode
  • Those who have a suicidal risk
  • Those who are likely to require prohibited concomitant therapy during the trial
  • Those who have received treatment with a monoamine oxidase inhibitor within 2 weeks prior to enrollment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01488266

Locations
Korea, Republic of
Korean Univ Ansan Hospital; Bucheon St.Mary Hospital; DonggukUniv Gyeongju Hospital; Catholic University of Korea St. Paul's Hospital
Seoul, Korea, Republic of
Taiwan
Chang Gung Memorial Hospital; Kaohsiung Medical University Chung-ho Memorial Hospital
Taipei, Taiwan
Sponsors and Collaborators
Korea University
Korea OIAA
Taiwan Otsuka Pharm. Co., Ltd
Investigators
Study Chair: Changsu Han, MD,PhD, MHS Korea Univ Ansan Hospital
  More Information

No publications provided

Responsible Party: Chansu Han, MD, PhD, MHS, Associate Professor of Psychiatry, Korea University School of Medicine, Korea University
ClinicalTrials.gov Identifier: NCT01488266     History of Changes
Other Study ID Numbers: CASCADE
Study First Received: December 4, 2011
Last Updated: December 6, 2011
Health Authority: Korea: Institutional Review Board
Korea: Food and Drug Administration
Taiwan : Food and Drug Administration
Taiwan: Institutional Review Board

Keywords provided by Korea University:
depression
depressive
major
aripiprazole
switching
augmentation
antidepressant

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Citalopram
Mirtazapine
Milnacipran
Venlafaxine
Aripiprazole
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Antidepressive Agents, Tricyclic
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents

ClinicalTrials.gov processed this record on August 19, 2014