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The purpose of this study is to determine whether combination of antidepressant drugs plus interpersonal psychotherapy is superior to antidepressant drugs alone in treatment resistant depression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IPT+antidepressant drugs | Experimental | Interpersonal Psychotherapy protocol (IPT) consist of 16 sessions of manualized interpersonal psychotherapy for depression. Patients are allowed to reschedule 3 sessions if they miss their appointments. Antidepressant Drugs protocol consist of pharmacological management of depression, oriented by international guidelines, clinician´s free choice. Monotherapy or combinations are allowed. Antidepressant and drugs are: fluoxetine, sertraline, paroxetin, citalopram, escitalopram, fluvoxamine, venlafaxin, duloxetin, bupropion, lithium, risperidone, tranylcypromine, Imipramine, amitriptyline, clomipramine, nortriptyline, trazodone, mirtazapine, sulpiride. |
|
| Antidepressant Drugs | Active Comparator | Drugs protocol consist of pharmacological management of depression, oriented by international guidelines, clinician´s free choice. Antidepressant Drugs protocol consist of pharmacological management of depression, oriented by international guidelines, clinician´s free choice. Monotherapy or combinations are allowed. Antidepressant and drugs are: fluoxetine, sertraline, paroxetine, citalopram, escitalopram, fluvoxamine, venlafaxine, duloxetine, bupropion, lithium, risperidone, tranylcypromine, Imipramine, amitriptyline, clomipramine, nortriptyline, trazodone, mirtazapine, sulpiride. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IPT+ antidepressant drugs | Other | 16 sessions of interpersonal psychotherapy plus antidepressant drugs. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Scale (HAM-D) - continuous | Score change on Hamilton depression scale from baseline to week 19 and to week 24 | End point week 19 and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Beck depression Inventory (BDI) | Score change on Beck depression inventory from baseline to week 19 and to week 24 | End point week 19 and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression - Severity Scale (CGI-S) / dichotomous | Endpoint (week-19) and week 24 | |
| Whoqol brief - World Health Organization Quality of Life Instrument - Short version - Brazilian version | Score change in Whoqol-breef from baseline to week 19 and week 24 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Livia H Souza, MD | Contact | +55 51 98658701 | liviahartmanndesouza@gmail.com | |
| Marcelo PA Fleck, PhD | Contact | +55 51 33598294 | mfleck.voy@terra.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Marcelo PA Fleck, MD,PhD | Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre (HCPA) | Recruiting | Porto Alegre | Rio Grande do Sul | 90035-003 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26799332 | Derived | Souza LH, Salum GA, Mosqueiro BP, Caldieraro MA, Guerra TA, Fleck MP. Interpersonal psychotherapy as add-on for treatment-resistant depression: A pragmatic randomized controlled trial. J Affect Disord. 2016 Mar 15;193:373-80. doi: 10.1016/j.jad.2016.01.004. Epub 2016 Jan 8. |
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| fluoxetine | Drug | Antidepressant drugs, clinician´s free choice oriented by guidelines. Monotherapy or combinations are allowed |
|
| sertraline | Drug |
|
| paroxetine | Drug |
|
| Citalopram | Drug |
|
| escitalopram | Drug |
|
| fluvoxamine | Drug |
|
| Venlafaxine | Drug |
|
| Duloxetine | Drug |
|
| Bupropion | Drug |
|
| Lithium | Drug |
|
| Risperidone | Drug |
|
| tranylcypromine | Drug |
|
| Imipramine | Drug |
|
| amitriptyline | Drug |
|
| Clomipramine | Drug |
|
| nortriptyline | Drug |
|
| trazodone | Drug |
|
| Mirtazapine | Drug |
|
| sulpiride | Drug |
|
| Endpoint week 19 and week 24 |
| Biological measures - BDFN, TBARS, TNF-alfa, IL-1, IL-6 | A blood sample will be collected at baseline, week 19 and week 24. Change in serum biomarkers will be evaluated - BDFN (Brain derived neurotrophic factor), TBARS (thiobarbituric acid reactive substance), TNF-alfa (tumor necrosis factor alfa), IL-1 (interleukin-1), IL-6 (interlekin-6) before and after treatment. | End point week 19 and Week 24 |
| ID | Term |
|---|---|
| D061218 | Depressive Disorder, Treatment-Resistant |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000079062 | Interpersonal Psychotherapy |
| D000928 | Antidepressive Agents |
| D005473 | Fluoxetine |
| D020280 | Sertraline |
| D017374 | Paroxetine |
| D015283 | Citalopram |
| D000089983 | Escitalopram |
| D016666 | Fluvoxamine |
| D000069470 | Venlafaxine Hydrochloride |
| D000068736 | Duloxetine Hydrochloride |
| D016642 | Bupropion |
| D008094 | Lithium |
| D018967 | Risperidone |
| D014191 | Tranylcypromine |
| D007099 | Imipramine |
| D000639 | Amitriptyline |
| D002997 | Clomipramine |
| D009661 | Nortriptyline |
| D014196 | Trazodone |
| D000078785 | Mirtazapine |
| D013469 | Sulpiride |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D011619 | Psychotropic Drugs |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D015057 | 1-Naphthylamine |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010091 | Oximes |
| D006898 | Hydroxylamines |
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D008055 | Lipids |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011427 | Propiophenones |
| D007659 | Ketones |
| D008672 | Metals, Alkali |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
| D008670 | Metals |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D010879 | Piperazines |
| D011728 | Pyridones |
| D011725 | Pyridines |
| D001549 | Benzamides |
| D000577 | Amides |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
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