Cost- Effectiveness and Quality of Life Assessment in Mood Disorder

NCT02870283 | Completed Phase 4 Results DMC

• 1 other identifier: 09-013
• Study Type: interventional
• Target: 107
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the effectiveness of three systematic interventions for Bipolar Disorder (BD) mixed episodes 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 bipolar mixed episodes.

Conditions

Bipolar Disorder

Keywords

Cost effectiveness; Bipolar disorder; Mixed episodes; Quality of life

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)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

Secondary Outcomes (2)

• Number of Participants With Remission to Treatment

  8 months

• Quality of Life - WHOQOL Bref Intrument

  12 weeks

Study Arms (3)

Lithium

ACTIVE COMPARATOR

Subjects were randomized into three groups: (lithium, valproic acid, or carbamazepine). Group (A) Started Lithium (900mg-1500mg) Subjects evaluated for responsiveness every 2 weeks. Responsive to treatment patients remain in the same step. Max. step duration of 8 weeks. 1. First step: Monotherapy with Lithium (900-1500mg) Non responsive patients: 2nd step. 2. Second step: Randomization for lithium (900mg-1500mg) + valproic acid (1000mg-1500mg) OR lithium (900mg-1500mg) + carbamazepine (600mg-1200mg). Non responsive patients: 3rd step. 3. Third step: Crossover lithium (900mg-1500mg) + valproic acid (1000mg-1500mg) X lithium (900mg-1500mg) + carbamazepine (600mg-1200mg). Non responsive patients: 4th step. 4. Fourth step: Association with risperidone (1-6mg)

Drug: Lithium

Acid Valproic

ACTIVE COMPARATOR

Subjects were randomized into three groups: (lithium, valproic acid, or carbamazepine). Group (B) Started Valproic Acid (1000mg-1500mg). Subjects evaluated for responsiveness every 2 weeks. Responsive to treatment patients remain in the same step. Max. step duration of 8 weeks. 1. First step: Monotherapy with Valproic Acid (1000mg-1500mg) Non responsive patients: 2nd step. 2. Second step: Association with lithium (900mg-1500mg). Non responsive patients: 3rd step. 3. Third step: Crossover: lithium (900mg-1500mg) + carbamazepine (600mg-1200mg). Non responsive patients: 4th step. 4. Fourth step: Association with risperidone (1-6mg)

Drug: Valproic Acid

Carbamazepine

ACTIVE COMPARATOR

Subjects were randomized into three groups: (lithium, valproic acid, or carbamazepine). Group (C) Started Carbamazepine (600mg-1200mg). Subjects evaluated for responsiveness every 2 weeks. Responsive to treatment patients remain in the same step. Max. step duration of 8 weeks. 1. First step: Monotherapy with Carbamazepine (600mg-1200mg). Non responsive patients: 2nd step. 2. Second step: Association with lithium (900mg-1500mg). Non responsive patients: 3rd step. 3. Third step: Crossover: lithium (900mg-1500mg) + valproic acid (1000mg-1500mg). Non responsive patients: 4th step. 4. Fourth step: Association with risperidone (1-6mg)

Drug: Carbamazepine

Interventions

Lithium DRUG

Also known as: carbolitium

Lithium

Valproic Acid DRUG

Also known as: depakene

Acid Valproic

Carbamazepine DRUG

Also known as: tegretol

Carbamazepine

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; Valproic Acid; Carbamazepine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals; Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dra. Ana Flávia Silva Lima
• Organization: Universidade Federal do Rio Grande do Sul

afbslima@gmail.com

+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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 26, 2016
• First Posted: August 17, 2016
• Study Start: May 1, 2010
• Primary Completion: November 1, 2014
• Study Completion: September 1, 2015
• Last Updated: November 20, 2020
• Results First Posted: September 2, 2020

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share