Interpersonal Psychotherapy for Treatment Resistant Depression

Treatment Resistant Depression Clinical Trial

Official title:

Efficacy of Interpersonal Psychotherapy in Treatment Resistant Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01896349
• Other study ID #: TIP-120288
• Status: Recruiting
• Phase: N/A
• First received: July 1, 2013
• Last updated: July 10, 2013
• Start date: April 2013
• Est. completion date: November 2014

Study information

• Verified date: July 2013
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Livia H Souza, MD
• Phone: +55 51 98658701
• Email: liviahartmanndesouza[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: November 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Treatment-Resistant
• Treatment Resistant Depression

Intervention

Other:
• IPT+ antidepressant drugs
16 sessions of interpersonal psychotherapy plus antidepressant drugs.

Drug:
• fluoxetine
Antidepressant drugs, clinician´s free choice oriented by guidelines. Monotherapy or combinations are allowed
• sertraline

• paroxetine

• Citalopram

• escitalopram

• fluvoxamine

• Venlafaxine

• Duloxetine

• Bupropion

• Lithium

• Risperidone

• tranylcypromine

• Imipramine

• amitriptyline

• Clomipramine

• nortriptyline

• trazodone

• Mirtazapine

• sulpiride

Locations

Country	Name	City	State
Brazil	Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre (HCPA)	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical Global Impression - Severity Scale (CGI-S) / dichotomous		Endpoint (week-19) and week 24	No
Other	Whoqol brief - World Health Organization Quality of Life Instrument - Short version - Brazilian version	Score change in Whoqol-breef from baseline to week 19 and week 24	Endpoint week 19 and week 24	No
Other	Biological measures - BDFN, TBARS, TNF-alfa, IL-1, IL-6	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.	End point week 19 and Week 24	Yes
Primary	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	No
Secondary	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	No