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Interpersonal Psychotherapy for Treatment Resistant Depression

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ClinicalTrials.gov Identifier: NCT01896349
Recruitment Status : Unknown
Verified July 2013 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Recruiting
First Posted : July 11, 2013
Last Update Posted : July 11, 2013
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 2013
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. Clinical Global Impression - Severity Scale (CGI-S) / dichotomous [ Time Frame: Endpoint (week-19) and week 24 ]
  2. 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

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01896349     History of Changes
Other Study ID Numbers: TIP-120288
First Posted: July 11, 2013    Key Record Dates
Last Update Posted: July 11, 2013
Last Verified: July 2013

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Citalopram
Bupropion
Duloxetine Hydrochloride
Sertraline
Lithium Carbonate
Fluoxetine
Paroxetine
Venlafaxine Hydrochloride
Mirtazapine
Amitriptyline
Trazodone
Nortriptyline
Fluvoxamine
Imipramine
Clomipramine
Tranylcypromine
Sulpiride
Risperidone
Amitriptyline, perphenazine drug combination
Dexetimide
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents