Cost- Effectiveness and Quality of Life Assessment in Bipolar Disorder Depressive Episode

NCT02918097 | Completed Phase 4 Results DMC

• 1 other identifier: 09-013/2
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the effectiveness of an algorithm for Bipolar Disorder depressive episodes (BDD) using medications available in the Brazilian Public Healthcare System (SUS). Quality of life assessment of these patients was also employed. A randomized pragmatic trial was conducted. An algorithm was developed for the treatment of episodes of bipolar disorder depression episodes.

Conditions

Bipolar Disorder

Keywords

Cost effectiveness; Bipolar disorder; Depressive episodes; Quality of Life

Outcome Measures

Primary Outcomes (2)

• 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)and Young Mania Rating Scale (YMRS) scales HRSD was developed to evaluate and quantify depression.Its abbreviated version,. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal. The cutoff points are: 8-17 for mild depression,18-24 for moderate depression, and 25 or more for severe depression. The maximum score being 52 on the 17-point scale. YMRS is is the most widely used assessment tool for manic symptoms. The scale consists of 11 items .The YMRS follows the style of the Hamilton Rating Scale for Depression (HAM-D) with each item given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/agressive behavior), while the remaining seven items are graded on a 0 to 4 scale. Scores of YMRS \> 20 generates indicate mania

  8 weeks

• Quality of Life Instrument Scores

  Quality of Life - WHOQOL -BREF instrument scores scores 0-20 . higher scores mean a better outcome.

  12 weeks

Secondary Outcomes (1)

• Number of Participants With Remission to Treatment

  8 months

Study Arms (1)

Lithium Carbonate

EXPERIMENTAL

Group Started: Lithium Carbonate (900mg-1500mg) 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 Lithium (LSL 0.6-0.8). Non responsive patients: 2nd step. Second step: Monotherapy with lithium (LSL 1.0-1.2). Non responsive patients: 3rd step. Third step: Lithium + Sertraline (50mg-200mg). Non responsive patients: 4th step. Fourth step: Lithium + Nortriptyline 100mg. Non responsive patients: 5th step. Fifth step: Lithium + Nortriptyline 100mg + Sertraline (100mg-200mg). Non responsive patients: 6th step Sixth step: Lithium + Nortriptyline 100mg + Sertraline 200mg + Risperidone (1mg-6mg).

Drug: Lithium Carbonate; Drug: Sertraline; Drug: Nortriptyline; Drug: Risperidone

Interventions

Lithium Carbonate DRUG

Also known as: Carbolitium

Lithium Carbonate

Sertraline DRUG

Also known as: Zoloft

Lithium Carbonate

Nortriptyline DRUG

Also known as: Pamelor

Lithium Carbonate

Risperidone DRUG

Also known as: Risperdal

Lithium Carbonate

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;
• BD current acute mixed 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

Bipolar Disorder

Interventions

Lithium Carbonate; Sertraline; Nortriptyline; Risperidone

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbonates; Alkalies; Inorganic Chemicals; Carbonic Acid; Carbon Compounds, Inorganic; Lithium Compounds; 1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Dibenzocycloheptenes; Benzocycloheptenes; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic 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

5551999185180

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: This is a pragmatical clinical trial. The patients follow a pre-established algorithm About the participant flow the results the table to indicate the number of participants who received treatment in the whole algoritm, not in each step.

Study Record Dates

• First Submitted: September 25, 2016
• First Posted: September 28, 2016
• Study Start: May 1, 2010
• Primary Completion: November 1, 2014
• Study Completion: September 1, 2015
• Last Updated: November 20, 2020
• Results First Posted: October 14, 2020

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share