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

NCT01488266 | Unknown

• 1 other identifier: CASCADE
• Study Type: interventional
• Target: 90
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Major Depressive Disorder

Keywords

depression; depressive; major; aripiprazole; switching; augmentation; antidepressant

Outcome Measures

Primary Outcomes (2)

• Change of total score of MADRS

  MADRS: montgomery Asberg Depression Rating Scale

  From baseline to end of treatment

• Response rate

  response rate is defined as a reduction in MADRS total score of at least 50% relative to the beginning of the randomized phase (baseline)

  at 2 weeks

Secondary Outcomes (7)

• Response rate

  at week 2,4 and 6

• Remission rate

  at week 2,4and 6

• Change of total score of HDRS-17

  from baseline to end of treatment

• Change of total score of CGI-S

  from baseline to end of treatment

• Change of total score of IFS

  from baseline to end of treatment

Study Arms (2)

aripiprazole augmentation

EXPERIMENTAL

Drug: Aripiprazole

different class of antidepressant

ACTIVE COMPARATOR

Drug: switching to different class of antidepressant

Interventions

Aripiprazole DRUG

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.

Also known as: abilify

aripiprazole augmentation

switching to different class of antidepressant DRUG

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.

Also known as: escitalopram, fluoxetine, paroxetine, sertraline, bupropion XL, mirtazapine, venlafaxine, milnacipran, duloxetine

different class of antidepressant

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[same criteria for generic medications as brand drugs\]

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University: lead
• Korea OIAA: collaborator
• Taiwan Otsuka Pharm. Co., Ltd: collaborator

Study Sites (2)

Korean Univ Ansan Hospital; Bucheon St.Mary Hospital; DonggukUniv Gyeongju Hospital; Catholic University of Korea St. Paul's Hospital

Seoul, South Korea

Location

Chang Gung Memorial Hospital; Kaohsiung Medical University Chung-ho Memorial Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Aripiprazole; Escitalopram; Fluoxetine; Paroxetine; Sertraline; Mirtazapine; Venlafaxine Hydrochloride; Milnacipran; Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Piperidines; 1-Naphthylamine; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Phenethylamines; Ethylamines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Lipids; Cyclopropanes; Thiophenes; Sulfur Compounds

Study Officials

• Changsu Han, MD,PhD, MHS

  Korea Univ Ansan Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry, Korea University School of Medicine

Study Record Dates

• First Submitted: December 4, 2011
• First Posted: December 8, 2011
• Study Start: November 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: March 1, 2013
• Last Updated: December 8, 2011

Record last verified: 2011-12

Locations

TW (1); KR (1)