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Completed

NCT Number: NCT01696617

Aripiprazole (Abilify®) as an Adjunctive Treatment for Inadequate Response in Major Depressive Disorder

The investigators hypothesized that combined pharmacotherapy using adjunctive aripiprazole of standard antidepressants would be associated with improved depression response in Major depressive disorder, especially in Quality of life.

The investigators compare the mean changes in the quality of life between before add-on and 8 weeks treatment of aripiprazole and between before add-on and 6 weeks treatment of aripiprazole.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

Previous study about quality of life measurement in patients with depression have been reported that quality of life have to be measured irrespective with the severity of depression because quality of life has some other aspect to depression.The investigators have designed a 6-week single blinded study with flexible dose aripiprazole augmentation, ranging from 2.5mg to maximum 20 mg (15mg for patients on fluoxetine or paroxetine), in patients who responded inadequately (a score of >18 on the MADRS) to first-line antidepressant pharmacotherapy. The investigators compare the mean changes from in the quality of life at 8 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age : 18-65
  • Patients with major depressive disorder according to DSM-IV criteria that have lasted >8 weeks
  • MADRS total score of 18 or higher
  • Patients who responded inadequately (a score of >18 on the MADRS) to first-line antidepressant treatment of 4 week duration
  • Current use of standard antidepressant treatment in monotherapy or combination of 2 antidepressants : escitalopram (10 - 20mg/d), fluoxetine(20 - 40mg/d), paroxetine CR(25 - 50mg/d), sertraline(100 - 150mg/d), mirtazapine (15 - 45mg/d), duloxetine (30 - 60mg/d) or venlafaxine ER(150-225mg/d)

Exclusion criteria

  • Past history of hypersensitivity to aripiprazole
  • Primary diagnosis of MDD with psychotic feature, bipolar disorder, schizophrenia, schizoaffective disorder, other psychotic disorder or anxiety disorder, a history of alcohol/ drug abuse within the past 12 months, or a diagnosis of dementia
  • Clinically significant current Axis II (DSM-IV-TR) diagnosis
  • A significant risk of suicide corroborated by a score of ≥5 on item 10(suicidal thoughts) on the MADRS scale or by clinical judgment of the investigator
  • Pregnancy or in breast-feeding
  • Presence of a serious medical illness including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic, or hematologic disease or physical disorder judged to significantly affect central nervous system function
  • Patients taking antipsychotics, mood stabilizer or any psychotropic medications besides antidepressants, except benzodiazepines or beta blockers or hypnotics
  • Patients with past treatment failures of aripiprazole

Treatment and study plan

Aripiprazole 6-week group

Drug

Other names: Abilify®

Aripiprazole 8-week group

Drug

Other names: Abilify®

Primary outcomes

  1. Quality of Life Scale (QOLS)

    Time frame: Change from Baseline at 8 weeks

    change of Quality of Life Scale (QOLS)

Secondary outcomes

  1. Montgomery-Åsberg Depression Rating Scale

    Time frame: Change from Baseline at 8 weeks

    change of Montgomery-Åsberg Depression Rating Scale

Other outcomes

  1. Hamilton Rating Scale for Depression

    Time frame: Change from Baseline at 8 weeks

    change of Hamilton Rating Scale for Depression

  2. Clinical Global Impression-severity, Clinical Global Impression-Improvement

    Time frame: Change from Baseline at 8 weeks

    change of Clinical Global Impression-severity, Clinical Global Impression-Improvement

  3. Beck Depression Inventory

    Time frame: Change from Baseline at 8 weeks

    change of Beck Depression Inventory

  4. Inventory of Depressive Symptomatology Self-Report Scale

    Time frame: Change from Baseline at 8 weeks

    change of Inventory of Depressive Symptomatology Self-Report Scale

  5. Drug - Induced Extrapyramidal Symptoms Scale

    Time frame: Change from Baseline at 8 weeks

    change of Drug - Induced Extrapyramidal Symptoms Scale

  6. The Liverpool University Neuroleptic Side Effect Rating Scale

    Time frame: Change from Baseline at 8 weeks

    change of The Liverpool University Neuroleptic Side Effect Rating Scale

  7. Short From-36 Health survey

    Time frame: Change from Baseline at 8 weeks

    change of Short From-36 Health survey

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2019
First posted
Oct 1, 2012
Registry last updated
Apr 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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