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Treatment Resistant DepressionNCT01896349

Interpersonal Psychotherapy for Treatment Resistant Depression

A study testing IPT+ antidepressant drugs, fluoxetine and sertraline in people with Treatment Resistant Depression, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Treatment Resistant Depression
What is being tested?
IPT+ antidepressant drugs, fluoxetine and sertraline
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 siteBrazil
Study dates
Apr 2013to Nov 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Primary diagnose of unipolar treatment resistant depression

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Livia H Souza, MD contact

+55 51 98658701

liviahartmanndesouza@gmail.com

Marcelo PA Fleck, PhD contact

+55 51 33598294

mfleck.voy@terra.com.br

Brazil1 site, 1 recruiting

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

    Porto Alegre, Rio Grande do Sul, 90035-003

    Lívia H Souza, MD, +55 5198658701, livia.hs@terra.com.br

    Marcelo PA Fleck, MD, PhD, +55 51 33598294, mfleck.voy@terra.com.br

    Recruiting

Other trials in Brazil

About this study

Official title: 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.

Being tested
IPT+ antidepressant drugs, fluoxetine, sertraline, paroxetine, Citalopram
Keywords
Psychotherapy, Treatment Resistant Depression, depression
Medical subject headings
Depressive Disorder, Treatment-Resistant, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IPT+ antidepressant drugsOther

    Also called Interpersonal Psychotherapy, Antidepressant drugs

    16 sessions of interpersonal psychotherapy plus antidepressant drugs.

  • fluoxetineDrug

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

  • sertralineDrug

  • paroxetineDrug

  • CitalopramDrug

  • escitalopramDrug

  • fluvoxamineDrug

  • VenlafaxineDrug

  • DuloxetineDrug

  • BupropionDrug

  • LithiumDrug

  • RisperidoneDrug

  • tranylcypromineDrug

  • ImipramineDrug

  • amitriptylineDrug

  • ClomipramineDrug

  • nortriptylineDrug

  • trazodoneDrug

  • MirtazapineDrug

  • sulpirideDrug

Study groups in NCT01896349
Study groupRoleWhat they receive
IPT+antidepressant drugsExperimentalInterpersonal 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.
Receives: 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
Antidepressant DrugsActive comparatorDrugs 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.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hamilton Depression Scale (HAM-D) - continuous

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

    Measured: End point week 19 and Week 24

Secondary outcomes (1)

  1. Beck depression Inventory (BDI)

    Score change on Beck depression inventory from baseline to week 19 and to week 24

    Measured: End point week 19 and Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionAug 2014 (estimated)
  4. Study completionNov 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
74 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01896349
Sponsor's protocol ID
TIP-120288
Status last verified
Jul 2013
First submitted
1 Jul 2013
Last updated
11 Jul 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 26799332

Questions about this trial

What is this clinical trial studying?

A study testing IPT+ antidepressant drugs, fluoxetine and sertraline in people with Treatment Resistant Depression, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Livia H Souza, MD (+55 51 98658701, liviahartmanndesouza@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hamilton Depression Scale (HAM-D) - continuous (time frame: End point week 19 and Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01896349, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2013.

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