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

• Sponsor: Federal University of Rio Grande do Sul (Other)
• Overall Status: Completed
• CT.gov ID: NCT02901249
• Collaborator: (none)
• Enrollment: 68
• Arm: 1
• Duration (Months): 64

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression	Drug: sertraline; Drug: Nortriptyline; Drug: Lithium	Phase 4

Detailed Description

The study design was that of a pragmatic randomized clinical trial to evaluate the effectiveness of treatments for mood disorders in a public healthcare context in the city of Porto Alegre, in southern Brazil. The algorithm was originally developed for the treatment of major depression by a Delphi panel of experts from psychiatric associations in Brazil. All subjects provided an informed consent form, in writing, in order to participate in the study protocol, which was approved by the institutional ethics committee.

Procedures and measurements of the study

The subjects under evaluation were selected and they followed the stages defined by the treatment protocol:

1. Sample selection by being referred from the primary healthcare clinics in the municipality;

2. Informative talk about mood disorders and the research, with the informed consent forms being provided to the subjects;

3. Screening for unipolar depression episodes with the use of the Patient Health Questionnaire (PHQ-9), and Hypomanic Symptoms Checklist Brazilian Version (HCL -32-BV);

4. Diagnostic evaluation through the Mini International Neuropsychiatric Interview (MINI) and clinical interview for individuals with positive results in the screening instruments;

5. Baseline and demographic assessments using standardized semi-structured interviews in the first and second visits;

6. In each clinic visit, the severity of the symptoms were evealuated using the Clinical Global Impression Scale (CGI), Hamilton Rating Scale for Depression (HRSD), and Young Manic Rating Scale (YMRS);

7. Biweekly follow-up, changed to monthly after stabilization - with a maximum follow-up period of 52 weeks.

Study Design

• Study Type: Interventional
• Actual Enrollment: 68 participants
• Allocation: N/A
• Intervention Model: Sequential Assignment
• Intervention Model Description: 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.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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Assessment of Cost- Effectiveness Interventions and the Quality of Life in Patients With Major Depression Through Resources Available in Brazilian Public Health
• Study Start Date: May 1, 2010
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Sertraline 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; Other Names: Cloridrate of sertraline ; Drug: Nortriptyline; Other Names: Cloridrate of nortrytyline ; Drug: Lithium; Other Names: Lithium Carbonate

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Response to Treatment [8 weeks]

   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 .

Secondary Outcome Measures

1. Number of Participants With Remission to Treatment [8 months]

   The remission outcome was established as obtaining three consecutive scores of values considered asymptomatic in the Hamilton Rating Scale for Depression (HRSD <7 points) . The subjects that were asymptomatic for at least 6-8 month were considered to be in remission, according to the criteria for partial and complete remission in the DSM-IV.

2. Quality of Life -WHOQOL Intrument Scores [12 weeks]

   QOL scores as measured by World Heath Organization Quality of Life - WHOQOL -BREF instrument. scores 0-20 . Higher scores means a better outcome. The measure presented is a overall domain with the mean (SD)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. ages between 18 and 65;

2. current acute unipolar depression episode;

3. total capacity to understand and respond to self-applied instruments;

4. the presence of symptoms in the last 30 days;

5. abstinence for at least 30 days for drug addicts

Exclusion Criteria:

1. presence of Organic Brain Syndrome (OBS);

2. pregnancy or lactation;

3. criteria for psychiatric hospitalization.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Federal University of Rio Grande do Sul

Investigators

• Principal Investigator: Marcelo Fleck, PhD, Federal University of Rio Grande do Sul

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ana Flávia Barros da Silva Lima, Principal Investigator, Federal University of Rio Grande do Sul
• ClinicalTrials.gov Identifier: NCT02901249
• Other Study ID Numbers: 017/2009
• First Posted: Sep 15, 2016
• Last Update Posted: Oct 14, 2020
• Last Verified: Aug 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Ana Flávia Barros da Silva Lima, Principal Investigator, Federal University of Rio Grande do Sul: Cost effectiveness; Unipolar Depression; Major Depression Disorder; Quality of life disorder
• Additional relevant MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Lithium Carbonate; Sertraline; Nortriptyline

Study Results

Participant Flow

Arm/Group Title	Sertraline
Arm/Group Description	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) sertraline Nortriptyline Lithium
Period Title: Overall Study
STARTED	68
COMPLETED	43
NOT COMPLETED	25

Baseline Characteristics

Arm/Group Title	Sertraline
Arm/Group Description	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) sertraline Nortriptyline Lithium
Overall Participants	68
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.4 (11.4)
Sex: Female, Male (Count of Participants)
Female	53 77.9%
Male	15 22.1%
Region of Enrollment (participants) [Number]
Brazil	68 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Response to Treatment
Description	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 .
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sertraline
Arm/Group Description	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) sertraline Nortriptyline Lithium
Measure Participants	68
Count of Participants [Participants]	58 85.3%

2. Secondary Outcome

Title	Number of Participants With Remission to Treatment
Description	The remission outcome was established as obtaining three consecutive scores of values considered asymptomatic in the Hamilton Rating Scale for Depression (HRSD <7 points) . The subjects that were asymptomatic for at least 6-8 month were considered to be in remission, according to the criteria for partial and complete remission in the DSM-IV.
Time Frame	8 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sertraline
Arm/Group Description	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) sertraline Nortriptyline Lithium
Measure Participants	68
Count of Participants [Participants]	32 47.1%

3. Secondary Outcome

Title	Quality of Life -WHOQOL Intrument Scores
Description	QOL scores as measured by World Heath Organization Quality of Life - WHOQOL -BREF instrument. scores 0-20 . Higher scores means a better outcome. The measure presented is a overall domain with the mean (SD)
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sertraline
Arm/Group Description	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) sertraline Nortriptyline Lithium
Measure Participants	68
Mean (Standard Deviation) [score on a scale]	9.45 (3.01)

Adverse Events

Time Frame	18 months
Arm/Group Title	Sertraline
Arm/Group Description	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) sertraline Nortriptyline Lithium
All Cause Mortality
	Sertraline
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Sertraline
	Affected / at Risk (%)	# Events
Total	0/68 (0%)
Other (Not Including Serious) Adverse Events
	Sertraline
	Affected / at Risk (%)	# Events
Total	0/68 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.