Cost- Effectiveness and Quality of Life Assessment in Major Depression Disorder

NCT02901249 | Completed Phase 4 Results DMC

• 1 other identifier: 017/2009
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the effectiveness of one algorithm for Major Depression Disorder (MDD) using medications available in the Brazilian Public Healthcare System (SUS), and assessment of the quality of life of these patients. A randomized pragmatic trial was conducted. An algorithm was developed for the treatment of episodes of unipolar depression episodes.

Conditions

Depression

Keywords

Cost effectiveness; Unipolar Depression; Major Depression Disorder; Quality of life disorder

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Response to Treatment

  Response to treatment was defined as a 50% reduction from baseline scores in Hamilton Rating Scale for Depression (HRSD). The HRSD is abbreviated version, consists of 17 items. The cutoff points are: 7-17 for mild depression,18-24 for moderate depression, and 25 or more for severe depression .

  8 weeks

Secondary Outcomes (2)

• Number of Participants With Remission to Treatment

  8 months

• Quality of Life -WHOQOL Intrument Scores

  12 weeks

Study Arms (1)

Sertraline

EXPERIMENTAL

Group Started: sertraline (50mg-200mg) Subjects evaluated for responsiveness every 2 weeks. Responsive to treatment patients remain in the same step. Max. step duration of 8 weeks. First step: Monotherapy with sertraline (50-200mg). Non responsive patients: 2nd step. Second step: Sertraline 200mg + lithium (900mg-1500mg) Non responsive patients: 3rd step. Third step: Nortriptyline 100mg Non responsive patients: 4th step. Fourth step: Nortriptyline 100mg + lithium (900mg-1500mg) Non responsive patients : 5th step Fifth step : Nortriptyline 100mg + sertraline 200mg Non responsive patients sixth step: Nortriptyline 100mg + sertraline 200mg + Lithium ( 900mg- 1500mg)

Drug: sertraline; Drug: Nortriptyline; Drug: Lithium

Interventions

sertraline DRUG

Also known as: Cloridrate of sertraline

Sertraline

Nortriptyline DRUG

Also known as: Cloridrate of nortrytyline

Sertraline

Lithium DRUG

Also known as: Lithium Carbonate

Sertraline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ages between 18 and 65;
• current acute unipolar depression episode;
• total capacity to understand and respond to self-applied instruments;
• the presence of symptoms in the last 30 days;
• abstinence for at least 30 days for drug addicts

You may not qualify if:

• presence of Organic Brain Syndrome (OBS);
• pregnancy or lactation;
• criteria for psychiatric hospitalization.

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead

Related Publications (1)

• Lima AF, Miguel SR, Cohen M, Zimmermann JJ, Shansis FM, Cruz LN, Ziegelmann PK, Polanczyk CA, Fleck MP. Effectiveness evaluation of mood disorder treatment algorithms in Brazilian public healthcare patients. Braz J Psychiatry. 2018 Jan-Mar;40(1):26-34. doi: 10.1590/1516-4446-2016-2147. Epub 2017 Aug 21.

  PMID: 28832750 DERIVED

MeSH Terms

Conditions

Depression; Depressive Disorder

Interventions

Sertraline; Nortriptyline; Lithium; Lithium Carbonate

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Dibenzocycloheptenes; Benzocycloheptenes; Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals; Carbonates; Alkalies; Carbonic Acid; Carbon Compounds, Inorganic; Lithium Compounds

Results Point of Contact

• Title: D.r. Ana Flávia Barros da Silva Lima
• Organization: Universidade Federal do Rio Grande do Sul

afbslima@gmail.com.br

51999185180

Study Officials

• Marcelo Fleck, PhD

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients start treatment according to the algorithm and follow a sequence of steps. There is no comparison between groups. It is a single group. Primary and secondary outcomes are only assessed at the end of the protocol, not at each step.

Study Record Dates

• First Submitted: September 11, 2016
• First Posted: September 15, 2016
• Study Start: May 1, 2010
• Primary Completion: November 1, 2014
• Study Completion: September 1, 2015
• Last Updated: October 14, 2020
• Results First Posted: October 14, 2020

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share