Interpersonal Psychotherapy for Treatment Resistant Depression

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Hospital de Clinicas de Porto Alegre
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT01896349
First received: July 1, 2013
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Interpersonal Psychotherapy in Treatment Resistant Depression

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Hamilton Depression Scale (HAM-D) - continuous [ Time Frame: End point week 19 and Week 24 ] [ Designated as safety issue: No ]
    Score change on Hamilton depression scale from baseline to week 19 and to week 24


Secondary Outcome Measures:
  • Beck depression Inventory (BDI) [ Time Frame: End point week 19 and Week 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Endpoint (week-19) and week 24 ] [ Designated as safety issue: No ]
  • Whoqol brief - World Health Organization Quality of Life Instrument - Short version - Brazilian version [ Time Frame: Endpoint week 19 and week 24 ] [ Designated as safety issue: No ]
    Score change in Whoqol-breef from baseline to week 19 and week 24

  • Biological measures - BDFN, TBARS, TNF-alfa, IL-1, IL-6 [ Time Frame: End point week 19 and Week 24 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 74
Study Start Date: April 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01896349

Contacts
Contact: Livia H Souza, MD +55 51 98658701 liviahartmanndesouza@gmail.com
Contact: Marcelo PA Fleck, PhD +55 51 33598294 mfleck.voy@terra.com.br

Locations
Brazil
Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre (HCPA) Recruiting
Porto Alegre, RS, Brazil, 90035-003
Contact: Lívia H Souza, MD    +55 5198658701    livia.hs@terra.com.br   
Contact: Marcelo PA Fleck, MD, PhD    +55 51 33598294    mfleck.voy@terra.com.br   
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         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01896349     History of Changes
Other Study ID Numbers: TIP-120288
Study First Received: July 1, 2013
Last Updated: July 10, 2013
Health Authority: Brazil: Ethics Committee
Brazil: National Committee of Ethics in Research

Keywords provided by Hospital de Clinicas de Porto Alegre:
Psychotherapy, Treatment Resistant Depression, depression

Additional relevant MeSH terms:
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents, Tricyclic
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders
Trazodone
Tranylcypromine
Fluvoxamine
Clomipramine
Citalopram
Fluoxetine
Paroxetine
Sertraline
Venlafaxine
Duloxetine
Sulpiride
Bupropion
Amitriptyline
Imipramine
Nortriptyline
Mirtazapine
Amitriptyline, perphenazine drug combination
Dexetimide
Lithium
Risperidone
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on August 28, 2014