NCT01896349

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 11, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

July 11, 2013

Status Verified

July 1, 2013

Enrollment Period

1.3 years

First QC Date

July 1, 2013

Last Update Submit

July 10, 2013

Conditions

Treatment Resistant Depression

Keywords

Psychotherapy, Treatment Resistant Depression, depression

Outcome Measures

Primary Outcomes (1)

  • Hamilton Depression Scale (HAM-D) - continuous

    Score change on Hamilton depression scale from baseline to week 19 and to week 24

    End point week 19 and Week 24

Secondary Outcomes (1)

  • Beck depression Inventory (BDI)

    End point week 19 and Week 24

Other Outcomes (3)

  • 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

  • Biological measures - BDFN, TBARS, TNF-alfa, IL-1, IL-6

    End point week 19 and Week 24

Study Arms (2)

IPT+antidepressant drugs

EXPERIMENTAL

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 drugsDrug: fluoxetineDrug: sertralineDrug: paroxetineDrug: CitalopramDrug: escitalopramDrug: fluvoxamineDrug: VenlafaxineDrug: DuloxetineDrug: BupropionDrug: LithiumDrug: RisperidoneDrug: tranylcypromineDrug: ImipramineDrug: amitriptylineDrug: ClomipramineDrug: nortriptylineDrug: trazodoneDrug: MirtazapineDrug: sulpiride

Antidepressant Drugs

ACTIVE COMPARATOR

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: fluoxetineDrug: sertralineDrug: paroxetineDrug: CitalopramDrug: escitalopramDrug: fluvoxamineDrug: VenlafaxineDrug: DuloxetineDrug: BupropionDrug: LithiumDrug: RisperidoneDrug: tranylcypromineDrug: ImipramineDrug: amitriptylineDrug: ClomipramineDrug: nortriptylineDrug: trazodoneDrug: MirtazapineDrug: sulpiride

Interventions

IPT+ antidepressant drugsOTHER

16 sessions of interpersonal psychotherapy plus antidepressant drugs.

Also known as: Interpersonal Psychotherapy, Antidepressant drugs
IPT+antidepressant drugs
fluoxetineDRUG

Antidepressant drugs, clinician´s free choice oriented by guidelines. Monotherapy or combinations are allowed

Antidepressant DrugsIPT+antidepressant drugs
sertralineDRUG
Antidepressant DrugsIPT+antidepressant drugs
paroxetineDRUG
Antidepressant DrugsIPT+antidepressant drugs
CitalopramDRUG
Antidepressant DrugsIPT+antidepressant drugs
escitalopramDRUG
Antidepressant DrugsIPT+antidepressant drugs
fluvoxamineDRUG
Antidepressant DrugsIPT+antidepressant drugs
VenlafaxineDRUG
Antidepressant DrugsIPT+antidepressant drugs
DuloxetineDRUG
Antidepressant DrugsIPT+antidepressant drugs
BupropionDRUG
Antidepressant DrugsIPT+antidepressant drugs
LithiumDRUG
Antidepressant DrugsIPT+antidepressant drugs
RisperidoneDRUG
Antidepressant DrugsIPT+antidepressant drugs
tranylcypromineDRUG
Antidepressant DrugsIPT+antidepressant drugs
ImipramineDRUG
Antidepressant DrugsIPT+antidepressant drugs
amitriptylineDRUG
Antidepressant DrugsIPT+antidepressant drugs
ClomipramineDRUG
Antidepressant DrugsIPT+antidepressant drugs
nortriptylineDRUG
Antidepressant DrugsIPT+antidepressant drugs
trazodoneDRUG
Antidepressant DrugsIPT+antidepressant drugs
MirtazapineDRUG
Antidepressant DrugsIPT+antidepressant drugs
sulpirideDRUG
Antidepressant DrugsIPT+antidepressant drugs

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary diagnose of unipolar treatment resistant depression

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

RECRUITING

Related Publications (1)

  • 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.

    PMID: 26799332DERIVED

MeSH Terms

Conditions

Depressive Disorder, Treatment-ResistantDepression

Interventions

Interpersonal PsychotherapyAntidepressive AgentsFluoxetineSertralineParoxetineCitalopramEscitalopramFluvoxamineVenlafaxine HydrochlorideDuloxetine HydrochlorideBupropionLithiumRisperidoneTranylcypromineImipramineAmitriptylineClomipramineNortriptylineTrazodoneMirtazapineSulpiride

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesPsychotropic DrugsCentral Nervous System AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesPropylaminesAminesOrganic Chemicals1-NaphthylamineNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingOximesHydroxylaminesCyclohexanolsHexanolsFatty AlcoholsAlcoholsPhenethylaminesEthylaminesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicLipidsThiophenesSulfur CompoundsPropiophenonesKetonesMetals, AlkaliElementsInorganic ChemicalsMetals, LightMetalsPyrimidinonesPyrimidinesDibenzazepinesHeterocyclic Compounds, 3-RingDibenzocycloheptenesBenzocycloheptenesPiperazinesPyridonesPyridinesBenzamidesAmidesBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene Derivatives

Study Officials

  • Marcelo PA Fleck, MD,PhD

    Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Livia H Souza, MD

CONTACT

+55 51 98658701liviahartmanndesouza@gmail.com

Marcelo PA Fleck, PhD

CONTACT

+55 51 33598294mfleck.voy@terra.com.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2013

First Posted

July 11, 2013

Study Start

April 1, 2013

Primary Completion

August 1, 2014

Study Completion

November 1, 2014

Last Updated

July 11, 2013

Record last verified: 2013-07

Locations

BR(1)