Bipolar DisorderPhase 4NCT02918097

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

A Phase 4 study testing Lithium Carbonate, Sertraline and Nortriptyline in people with Bipolar Disorder, run by Federal University of Rio Grande do Sul.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Bipolar Disorder
What is being tested?: Lithium Carbonate, Sertraline and Nortriptyline
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 78 participants
Where: No sites listed yet
Study dates: May 2010to Sep 2015
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

About this study

A randomized pragmatic trial was conducted. An algorithm was developed for the treatment of episodes of bipolar disorder depression episodes.

Read the 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 bipolar disorder depressive episodes 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:

Sample selection by being referred from the primary healthcare clinics in the municipality;
Informative talk about mood disorders and the research, with the informed consent forms being provided to the subjects;
Screening for unipolar depression episodes with the use of the Patient Health Questionnaire (PHQ-9), and Hypomanic Symptoms Checklist Brazilian Version (HCL -32-BV);
Diagnostic evaluation through the Mini International Neuropsychiatric Interview (MINI) and clinical interview for individuals with positive results in the screening instruments;
Baseline and demographic assessments using standardized semi-structured interviews in the first and second visits;
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);
Biweekly follow-up, changed to monthly after stabilization - with a maximum follow-up period of 52 weeks.

Conditions: Bipolar Disorder
Being tested: Lithium Carbonate, Sertraline, Nortriptyline, Risperidone
Keywords: Cost effectiveness, Bipolar disorder, Depressive episodes, Quality of Life
Medical subject headings: Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lithium CarbonateDrug
Also called Carbolitium
SertralineDrug
Also called Zoloft
NortriptylineDrug
Also called Pamelor
RisperidoneDrug
Also called Risperdal

Study groups in NCT02918097
Study group	Role	What they receive
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). Receives: Drug: Lithium Carbonate; Drug: Sertraline; Drug: Nortriptyline; Drug: Risperidone

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 8 weeks
Quality of Life Instrument Scores
Quality of Life - WHOQOL -BREF instrument scores
scores 0-20 . higher scores mean a better outcome.
Measured: 12 weeks

Secondary outcomes (1)

Number of Participants With Remission to Treatment
The remission outcome was established as obtaining three consecutive visits with scores of values considered asymptomatic Hamilton Rating Scale for Depression(HRSD <7 points) and Young Mania Rating Scale (YMRS <6 points) during the trial. The subjects that were asymptomatic for at least 6-8 month were considered to be in partial remission and complete if at least 12 months without symptoms, according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV).
Measured: 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2010Sep 2015

First posted28 Sep 2016 (estimated)
Study startMay 2010
Primary completionNov 2014
Study completionSep 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Bipolar DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Model description: 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.
Masking: None (open label)
Enrolment: 78 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02918097
Sponsor's protocol ID: 09-013/2
Status last verified: Sep 2016
First submitted: 25 Sep 2016
Last updated: 20 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

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.
PubMed 28832750

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Bipolar Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cost- Effectiveness and Quality of Life Assessment in Bipolar Disorder Depressive Episode
ClinicalTrials.gov ID: NCT02918097
Acronym / sponsor ID: 09-013/2
Conditions: Bipolar Disorder
Keywords: Cost effectiveness, Bipolar disorder, Depressive episodes, Quality of Life
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 78 participants (actual)
Lead sponsor: Federal University of Rio Grande do SulUniversity, hospital or other
Study start: May 2010
Primary completion: Nov 2014 (actual)
Study completion: Sep 2015 (actual)
First posted: 28 Sep 2016 (estimated)
Results: Posted 14 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A randomized pragmatic trial was conducted. An algorithm was developed for the treatment of episodes of bipolar disorder depression episodes.

Detailed description

Procedures and measurements of the study:

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

Sample selection by being referred from the primary healthcare clinics in the municipality;
Informative talk about mood disorders and the research, with the informed consent forms being provided to the subjects;
Screening for unipolar depression episodes with the use of the Patient Health Questionnaire (PHQ-9), and Hypomanic Symptoms Checklist Brazilian Version (HCL -32-BV);
Diagnostic evaluation through the Mini International Neuropsychiatric Interview (MINI) and clinical interview for individuals with positive results in the screening instruments;
Baseline and demographic assessments using standardized semi-structured interviews in the first and second visits;
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);
Biweekly follow-up, changed to monthly after stabilization - with a maximum follow-up period of 52 weeks.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1
Model description: 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.

Arm	Type	Receives
Lithium Carbonate	Experimental	Drug: Lithium Carbonate, Drug: Sertraline, Drug: Nortriptyline, Drug: RisperidoneGroup 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).

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lithium CarbonateAlso: Carbolitium	Drug	Lithium Carbonate
SertralineAlso: Zoloft	Drug	Lithium Carbonate
NortriptylineAlso: Pamelor	Drug	Lithium Carbonate
RisperidoneAlso: Risperdal	Drug	Lithium Carbonate

Primary outcome

Number of Participants With Response to Treatment"
Time frame: 8 weeks
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
Quality of Life Instrument Scores
Time frame: 12 weeks
Quality of Life - WHOQOL -BREF instrument scores scores 0-20 . higher scores mean a better outcome.

1 secondary outcome

Number of Participants With Remission to Treatment
Time frame: 8 months

Results and safety

Results posted to the registry on 14 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lithium Carbonate	78	58

Primary outcome: Number of Participants With Response to Treatment"

Time frame: 8 weeks. Count of participants. Unit: Participants

Measure	Lithium Carbonate n = 78
Value	65

Primary outcome: Quality of Life Instrument Scores

Time frame: 12 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Lithium Carbonate n = 78
Value	10.58 (3.64)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 18 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lithium Carbonate	0 of 78 (0%)	0 of 78 (0%)	0 of 78

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28832750Lima 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.
Individual participant dataSharing planned: No

Related trials for Bipolar Disorder

Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
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Recruiting
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Major Depressive Disorder (MDD), Bipolar Disorder (BD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marcelo Fleck, PhD principal investigator

Federal University of Rio Grande do Sul

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lithium Carbonate, Sertraline and Nortriptyline in people with Bipolar Disorder, run by Federal University of Rio Grande do Sul.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Response to Treatment" (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02918097, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.