Interpersonal Psychotherapy for Treatment Resistant Depression

NCT01896349 — Not applicable, Unknown, 74 participants, Hospital de Clinicas de Porto Alegre

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Efficacy of Interpersonal Psychotherapy in Treatment Resistant Depression

Registry	NCT01896349
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	74 (Estimated)
Sponsor	Hospital de Clinicas de Porto Alegre (Other)
Conditions	Treatment Resistant Depression
Interventions	IPT+ antidepressant drugs, fluoxetine, sertraline, paroxetine, Citalopram, escitalopram, fluvoxamine, Venlafaxine, Duloxetine, Bupropion, Lithium, Risperidone, tranylcypromine, Imipramine, amitriptyline, Clomipramine, nortriptyline, trazodone, Mirtazapine, sulpiride (Other, drug)
Dates	start 2013-04-01, primary completion 2014-08-01 (estimated), completion 2014-11-01 (estimated), first posted 2013-07-11, last updated 2013-07-11
Locations	1 site in Brazil

-Summary

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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+Arms and interventions

Arm	Type	Interventions	Description
IPT+antidepressant drugs	Experimental	Other: IPT+ antidepressant drugs; Drug: fluoxetine; Drug: 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	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	Drug: fluoxetine; Drug: 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	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.

IPT+ antidepressant drugs (Other), also known as Interpersonal Psychotherapy, Antidepressant drugs: 16 sessions of interpersonal psychotherapy plus antidepressant drugs.
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)

+Outcome measures

Primary outcomes

Hamilton Depression Scale (HAM-D) - continuous [End point week 19 and Week 24]: Score change on Hamilton depression scale from baseline to week 19 and to week 24

Secondary outcomes

Beck depression Inventory (BDI) [End point week 19 and Week 24]: Score change on Beck depression inventory from baseline to week 19 and to week 24

Other outcomes

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 [Endpoint week 19 and week 24]: Score change in Whoqol-breef from baseline to week 19 and week 24
Biological measures - BDFN, TBARS, TNF-alfa, IL-1, IL-6 [End point week 19 and Week 24]: 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.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Primary diagnose of unipolar treatment resistant depression

Exclusion Criteria:

* Patients diagnose of: bipolar disorder, psychosis, high suicide risk, Intellectual disability, illicit drug dependence.
* Currently in or having received psychotherapy in the last 4 weeks

+Locations (1)

Facility	City	Country	Status
Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre (HCPA)	Porto Alegre, Rio Grande do Sul	Brazil	Recruiting

+Publications

Results publication: 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. PMID 26799332

+Investigators

Marcelo PA Fleck, MD,PhD, Principal investigator, Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre