Interpersonal Psychotherapy for Treatment Resistant Depression

July 10, 2013 updated by: Hospital de Clinicas de Porto Alegre

Efficacy of Interpersonal Psychotherapy in Treatment Resistant Depression

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90035-003
        • Recruiting
        • Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre (HCPA)
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Lívia H Souza, MD
        • Principal Investigator:
          • Marcelo PA Fleck, MD, PhD
        • Sub-Investigator:
          • Marco Antonio K Caldieraro, MD, MSc
        • Sub-Investigator:
          • Lucas Spanemberg, MD
        • Sub-Investigator:
          • Edgar A Vares, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.
Drug: Duloxetine
Drug: paroxetine
Drug: Risperidone
Drug: escitalopram
Drug: Bupropion
Drug: Citalopram
Drug: Venlafaxine
Drug: sertraline
Drug: Lithium
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: fluvoxamine
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: Duloxetine
Drug: paroxetine
Drug: Risperidone
Drug: escitalopram
Drug: Bupropion
Drug: Citalopram
Drug: Venlafaxine
Drug: sertraline
Drug: Lithium
Drug: fluoxetine
Antidepressant drugs, clinician´s free choice oriented by guidelines. Monotherapy or combinations are allowed
Drug: fluvoxamine
Drug: tranylcypromine
Drug: Imipramine
Drug: amitriptyline
Drug: Clomipramine
Drug: nortriptyline
Drug: trazodone
Drug: Mirtazapine
Drug: sulpiride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hamilton Depression Scale (HAM-D) - continuous
Time Frame: End point week 19 and Week 24
Score change on Hamilton depression scale from baseline to week 19 and to week 24
End point week 19 and Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck depression Inventory (BDI)
Time Frame: End point week 19 and Week 24
Score change on Beck depression inventory from baseline to week 19 and to week 24
End point week 19 and Week 24

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impression - Severity Scale (CGI-S) / dichotomous
Time Frame: Endpoint (week-19) and week 24
Endpoint (week-19) and week 24
Whoqol brief - World Health Organization Quality of Life Instrument - Short version - Brazilian version
Time Frame: Endpoint week 19 and week 24
Score change in Whoqol-breef from baseline to week 19 and week 24
Endpoint week 19 and week 24
Biological measures - BDFN, TBARS, TNF-alfa, IL-1, IL-6
Time Frame: 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.
End point week 19 and Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Anticipated)

August 1, 2014

Study Completion (Anticipated)

November 1, 2014

Study Registration Dates

First Submitted

July 1, 2013

First Submitted That Met QC Criteria

July 10, 2013

First Posted (Estimate)

July 11, 2013

Study Record Updates

Last Update Posted (Estimate)

July 11, 2013

Last Update Submitted That Met QC Criteria

July 10, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TIP-120288

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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