Interpersonal Psychotherapy for Treatment Resistant Depression

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Interpersonal Psychotherapy in Treatment Resistant Depression

Conditions
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Treatment Resistant Depression

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IPT+antidepressant drugs<br>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<br>* 16 sessions of interpersonal psychotherapy plus antidepressant drugs.<br>* Other names: Antidepressant drugs;Drug: fluoxetine<br>* Antidepressant drugs, clinician´s free choice oriented by guidelines. Monotherapy or combinations are allowed<br>Drug: sertraline<br> <br> Drug: paroxetine<br> <br> Drug: Citalopram<br> <br> Drug: escitalopram<br> <br> Drug: fluvoxamine<br> <br> Drug: Venlafaxine<br> <br> Drug: Duloxetine<br> <br> Drug: Bupropion<br> <br> Drug: Lithium<br> <br> Drug: Risperidone<br> <br> Drug: tranylcypromine<br> <br> Drug: Imipramine<br> <br> Drug: amitriptyline<br> <br> Drug: Clomipramine<br> <br> Drug: nortriptyline<br> <br> Drug: trazodone<br> <br> Drug: Mirtazapine<br> <br> Drug: sulpiride<br> <br> |
| Active Comparator: Antidepressant Drugs<br>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<br>* Antidepressant drugs, clinician´s free choice oriented by guidelines. Monotherapy or combinations are allowed<br>Drug: sertraline<br> <br> Drug: paroxetine<br> <br> Drug: Citalopram<br> <br> Drug: escitalopram<br> <br> Drug: fluvoxamine<br> <br> Drug: Venlafaxine<br> <br> Drug: Duloxetine<br> <br> Drug: Bupropion<br> <br> Drug: Lithium<br> <br> Drug: Risperidone<br> <br> Drug: tranylcypromine<br> <br> Drug: Imipramine<br> <br> Drug: amitriptyline<br> <br> Drug: Clomipramine<br> <br> Drug: nortriptyline<br> <br> Drug: trazodone<br> <br> Drug: Mirtazapine<br> <br> Drug: sulpiride<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck depression Inventory (BDI) | Score change on Beck depression inventory from baseline to week 19 and to week 24 | End point week 19 and Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychotherapy, Treatment Resistant Depression, depression