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Interpersonal Psychotherapy for Treatment Resistant Depression

Primary Purpose

Treatment Resistant Depression

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
IPT+ antidepressant drugs
fluoxetine
sertraline
paroxetine
Citalopram
escitalopram
fluvoxamine
Venlafaxine
Duloxetine
Bupropion
Lithium
Risperidone
tranylcypromine
Imipramine
amitriptyline
Clomipramine
nortriptyline
trazodone
Mirtazapine
sulpiride
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment Resistant Depression focused on measuring Psychotherapy, Treatment Resistant Depression, depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre (HCPA)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IPT+antidepressant drugs

Antidepressant Drugs

Arm 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.

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.

Outcomes

Primary Outcome Measures

Hamilton Depression Scale (HAM-D) - continuous
Score change on Hamilton depression scale from baseline to week 19 and to week 24

Secondary Outcome Measures

Beck depression Inventory (BDI)
Score change on Beck depression inventory from baseline to week 19 and to week 24

Full Information

First Posted
July 1, 2013
Last Updated
July 10, 2013
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT01896349
Brief Title
Interpersonal Psychotherapy for Treatment Resistant Depression
Official Title
Efficacy of Interpersonal Psychotherapy in Treatment Resistant Depression
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
November 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Resistant Depression
Keywords
Psychotherapy, Treatment Resistant Depression, depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IPT+antidepressant drugs
Arm Type
Experimental
Arm 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.
Arm Title
Antidepressant Drugs
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
IPT+ antidepressant drugs
Other Intervention Name(s)
Interpersonal Psychotherapy, Antidepressant drugs
Intervention Description
16 sessions of interpersonal psychotherapy plus antidepressant drugs.
Intervention Type
Drug
Intervention Name(s)
fluoxetine
Intervention Description
Antidepressant drugs, clinician´s free choice oriented by guidelines. Monotherapy or combinations are allowed
Intervention Type
Drug
Intervention Name(s)
sertraline
Intervention Type
Drug
Intervention Name(s)
paroxetine
Intervention Type
Drug
Intervention Name(s)
Citalopram
Intervention Type
Drug
Intervention Name(s)
escitalopram
Intervention Type
Drug
Intervention Name(s)
fluvoxamine
Intervention Type
Drug
Intervention Name(s)
Venlafaxine
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Intervention Type
Drug
Intervention Name(s)
Bupropion
Intervention Type
Drug
Intervention Name(s)
Lithium
Intervention Type
Drug
Intervention Name(s)
Risperidone
Intervention Type
Drug
Intervention Name(s)
tranylcypromine
Intervention Type
Drug
Intervention Name(s)
Imipramine
Intervention Type
Drug
Intervention Name(s)
amitriptyline
Intervention Type
Drug
Intervention Name(s)
Clomipramine
Intervention Type
Drug
Intervention Name(s)
nortriptyline
Intervention Type
Drug
Intervention Name(s)
trazodone
Intervention Type
Drug
Intervention Name(s)
Mirtazapine
Intervention Type
Drug
Intervention Name(s)
sulpiride
Primary Outcome Measure Information:
Title
Hamilton Depression Scale (HAM-D) - continuous
Description
Score change on Hamilton depression scale from baseline to week 19 and to week 24
Time Frame
End point week 19 and Week 24
Secondary Outcome Measure Information:
Title
Beck depression Inventory (BDI)
Description
Score change on Beck depression inventory from baseline to week 19 and to week 24
Time Frame
End point week 19 and Week 24
Other Pre-specified Outcome Measures:
Title
Clinical Global Impression - Severity Scale (CGI-S) / dichotomous
Time Frame
Endpoint (week-19) and week 24
Title
Whoqol brief - World Health Organization Quality of Life Instrument - Short version - Brazilian version
Description
Score change in Whoqol-breef from baseline to week 19 and week 24
Time Frame
Endpoint week 19 and week 24
Title
Biological measures - BDFN, TBARS, TNF-alfa, IL-1, IL-6
Description
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.
Time Frame
End point week 19 and Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Livia H Souza, MD
Phone
+55 51 98658701
Email
liviahartmanndesouza@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marcelo PA Fleck, PhD
Phone
+55 51 33598294
Email
mfleck.voy@terra.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo PA Fleck, MD,PhD
Organizational Affiliation
Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre (HCPA)
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-003
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lívia H Souza, MD
Phone
+55 5198658701
Email
livia.hs@terra.com.br
First Name & Middle Initial & Last Name & Degree
Marcelo PA Fleck, MD, PhD
Phone
+55 51 33598294
Email
mfleck.voy@terra.com.br
First Name & Middle Initial & Last Name & Degree
Lívia H Souza, MD
First Name & Middle Initial & Last Name & Degree
Marcelo PA Fleck, MD, PhD
First Name & Middle Initial & Last Name & Degree
Marco Antonio K Caldieraro, MD, MSc
First Name & Middle Initial & Last Name & Degree
Lucas Spanemberg, MD
First Name & Middle Initial & Last Name & Degree
Edgar A Vares, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
26799332
Citation
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.
Results Reference
derived

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Interpersonal Psychotherapy for Treatment Resistant Depression

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