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Treatment Resistant Depression | Interpersonal Psychotherapy for Treatment Resistant Depression

Treatment Resistant Depression research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Treatment Resistant Depression

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:IPT+ antidepressant drugs16 sessions of interpersonal psychotherapy plus antidepressant drugs.

Drug:fluoxetineAntidepressant drugs, clinician´s free choice oriented by guidelines. Monotherapy or combinations are allowed

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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

IPT+antidepressant drugsInterpersonal 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 DrugsDrugs 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.

Study Status

Unknown status

Start Date: April 2013

Completed Date: November 2014

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Hamilton Depression Scale (HAM-D) - continuous

Secondary Outcome: Beck depression Inventory (BDI)

Study sponsors, principal investigator, and references

Principal Investigator: Marcelo PA Fleck, MD,PhD

Lead Sponsor: Hospital de Clinicas de Porto Alegre

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01896349

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