Interpersonal Psychotherapy for Treatment Resistant Depression

Sponsor

Hospital de Clinicas de Porto Alegre (Other)

Overall Status

Unknown status

CT.gov ID

NCT01896349

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Treatment Resistant Depression	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	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

74 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Efficacy of Interpersonal Psychotherapy in Treatment Resistant Depression

Study Start Date :

Apr 1, 2013

Anticipated Primary Completion Date :

Aug 1, 2014

Anticipated Study Completion Date :

Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IPT+antidepressant drugs 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.	Other: IPT+ antidepressant drugs 16 sessions of interpersonal psychotherapy plus antidepressant drugs. Other Names: Interpersonal Psychotherapy Antidepressant drugs Drug: fluoxetine Antidepressant 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
Active Comparator: Antidepressant Drugs 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.	Drug: fluoxetine Antidepressant 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

Arm

Intervention/Treatment

Experimental: IPT+antidepressant drugs

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.

Other: IPT+ antidepressant drugs

16 sessions of interpersonal psychotherapy plus antidepressant drugs.

Other Names:

Interpersonal Psychotherapy

Antidepressant drugs

Drug: fluoxetine

Antidepressant 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

Active Comparator: Antidepressant Drugs

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.

Drug: fluoxetine

Antidepressant 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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 Outcome Measures

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 Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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