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| Name | Class |
|---|---|
| Korea OIAA | UNKNOWN |
| Taiwan Otsuka Pharm. Co., Ltd | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aripiprazole augmentation | Experimental |
| |
| different class of antidepressant | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | at week 2,4 and 6 | |
| Remission rate | remission rate is defined as an absolute MADRS total score of ≤10 at the end of treatment | at week 2,4and 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Changsu Han, MD,PhD, MHS | Korea Univ Ansan Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korean Univ Ansan Hospital; Bucheon St.Mary Hospital; DonggukUniv Gyeongju Hospital; Catholic University of Korea St. Paul's Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| D000089983 | Escitalopram |
| D005473 | Fluoxetine |
| D017374 | Paroxetine |
| D020280 | Sertraline |
| D000078785 | Mirtazapine |
| D000069470 | Venlafaxine Hydrochloride |
| D000078764 | Milnacipran |
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
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|
|
| 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. |
|
|
| Change of total score of HDRS-17 | HDRS-17: Hamilton Depression Rating Scale-17 item | from baseline to end of treatment |
| Change of total score of CGI-S | CGI-S: Clinical Global Impression-Severity Score | from baseline to end of treatment |
| Change of total score of IFS | IFS: Iowa Fatigue Scale | from baseline to end of treatment |
| Change of total score of SDS | SDS: Sheehan Disability Scale | from baseline to end of treatment |
| Patients' ratio who have have scored 1 or 2 in the score of CGI-Improvement | CGI-I: Clinical Global Impression-Improvement Score | at the end of treatment |
| Chang Gung Memorial Hospital; Kaohsiung Medical University Chung-ho Memorial Hospital | Taipei | Taiwan |
| D001519 |
| Behavior |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D010880 | Piperidines |
| D015057 | 1-Naphthylamine |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D008055 | Lipids |
| D003521 | Cyclopropanes |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |