Interpersonal Psychotherapy for Treatment Resistant Depression

Hospital de Clinicas de Porto Alegre

Status: Unknown

Conditions: Treatment Resistant Depression

Treatments: Drug: trazodone; Drug: Risperidone; Drug: nortriptyline; Drug: Mirtazapine; Drug: Citalopram; Drug: tranylcypromine; Drug: Lithium; Other: IPT+ antidepressant drugs; Drug: sertraline; Drug: fluoxetine; Drug: Duloxetine; Drug: Venlafaxine; Drug: Bupropion; Drug: escitalopram; Drug: Clomipramine; Drug: paroxetine; Drug: sulpiride; Drug: amitriptyline; Drug: Imipramine; Drug: fluvoxamine

Study type: Interventional

Funder types: Other

Identifiers

NCT01896349

TIP-120288

Details and patient eligibility

About

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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 2 patient groups

IPT+antidepressant drugs

Experimental group

Description:

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.

Treatment:

Drug: Risperidone

Drug: Duloxetine

Drug: Mirtazapine

Drug: Bupropion

Drug: fluoxetine

Drug: Clomipramine

Drug: paroxetine

Drug: Venlafaxine

Drug: sertraline

Drug: sulpiride

Drug: amitriptyline

Drug: Citalopram

Drug: escitalopram

Other: IPT+ antidepressant drugs

Drug: nortriptyline

Drug: Lithium

Drug: fluvoxamine

Drug: Imipramine

Drug: tranylcypromine

Drug: trazodone

Antidepressant Drugs

Active Comparator group

Description:

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.

Treatment:

Drug: Risperidone

Drug: Duloxetine

Drug: Mirtazapine

Drug: Bupropion

Drug: fluoxetine

Drug: Clomipramine

Drug: paroxetine

Drug: Venlafaxine

Drug: sertraline

Drug: sulpiride

Drug: amitriptyline

Drug: Citalopram

Drug: escitalopram

Drug: nortriptyline

Drug: Lithium

Drug: fluvoxamine

Drug: Imipramine

Drug: tranylcypromine

Drug: trazodone