Trial Outcomes & Findings for Cost- Effectiveness and Quality of Life Assessment in Bipolar Disorder Depressive Episode (NCT NCT02918097)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

78 participants

Primary outcome timeframe

8 weeks

Results posted on

2020-11-20

Participant Flow

Participant milestones

Participant milestones
Measure	Lithium Carbonate 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). Lithium Carbonate Sertraline Nortriptyline Risperidone
Overall Study STARTED	78
Overall Study COMPLETED	58
Overall Study NOT COMPLETED	20

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lithium Carbonate n=78 Participants 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). Lithium Carbonate Sertraline Nortriptyline Risperidone
Age, Continuous	40.4 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	61 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment Brazil	78 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Lithium Carbonate n=78 Participants 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). Lithium Carbonate Sertraline Nortriptyline Risperidone
Number of Participants With Response to Treatment"	65 Participants

PRIMARY outcome

Timeframe: 12 weeks

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

Outcome measures

Outcome measures
Measure	Lithium Carbonate n=78 Participants 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). Lithium Carbonate Sertraline Nortriptyline Risperidone
Quality of Life Instrument Scores	10.58 score on a scale Standard Deviation 3.64

SECONDARY outcome

Timeframe: 8 months

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).

Outcome measures

Outcome measures
Measure	Lithium Carbonate n=78 Participants 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). Lithium Carbonate Sertraline Nortriptyline Risperidone
Number of Participants With Remission to Treatment	21 Participants

Adverse Events

Lithium Carbonate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

D.r. Ana Flávia Barros da Silva Lima

Universidade Federal do Rio Grande do Sul

Phone: 5551999185180

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place