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The Effect of a Six Week Intensified Pharmacological Treatment for Bipolar Depression Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.
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Trial · NCT05973786

Registered outcomes18

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 18 of 18

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ListOutcomeTime frameDescription
PrimaryComparing the change in symptom severity on Montgomery Asberg Depression Rating Scale6 weeks
Mean in symptom severity (EIPT vs. TAU) total score from baseline (visit 2) to end of treatment (visit 4). This is measured using the Montgomery Asberg Depression Rating Scale.Minimum score is 0, maximum score is 60. A bigger mean change means a better outcome
SecondaryCompare proportion of participants that is in symptomatic remission6 weeksComparison of the proportion of participants (EIPT vs. TAU) that is in symptomatic remission at visit 4. Remission is defined as a Montgomery Asberg Depression Rating scale score of ≤ 12.
SecondaryCompare the change in the severity and improvement CGI-S sub-scores6 weeks
To compare changes in the severity sub-score of the Clinical Global Impression Scale (CGI 2) between the two treatment arms (EIPT/TAU) over the six week treatment period (visit 2 versus visit 4). Higher scores indicate higher illness severity. Minimum score: 1, maximum score: 7
SecondaryCompare the change in the severity and improvement CGI-I sub-scores6 weeks
To compare mean changes in the total improvement sub-score of the Clinical Global Impression (CGI 2) between the two treatment arms (EIPT/TAU) over the six week treatment period (visit 2 versus visit 4). A higher score means lower treatment improvement. Minimum score: 1, maximum score: 7
SecondaryCompare the changes in the levels of depression and anxiety6 weeks
To compare changes in the levels of depression and anxiety as assessed with the Hospital Anxiety and Depression Scale between the two treatment arms (EIPT/TAU) over the four week treatment period (visit 2 versus visit 4). Lower scores mean less depression and anxiety.
SecondaryTo compare changes in cognitive performance as measured through the Trail Making Test6 weeks
To compare changes in cognitive performance as measured through the Trail Making Test between the two treatment arms over the four weeks treatment period (visit 2 versus visit 4). A lower time to complete the test means better cognitive performance.
SecondaryTo compare the changes in cognitive performance as measured through the Rey Auditory Verbal Learning Test6 weeks
To compare changes in cognitive performance as measured through the Rey Auditory Verbal Learning Test between the two treatment arms over the six weeks treatment period (visit 2 versus visit 4). A higher scores means better cognitive performance.
SecondaryTo compare the changes in subjective cognitive performance as measured through the Perceived Deficits Questionnaire6 weeks
To compare changes in cognitive performance as measured through the Perceived Deficits Questionnaire between the two treatment arms over the six weeks treatment period (visit 2 versus visit 4). A higher scores means worse subjective cognitive performance.
SecondaryTo compare the changes in functioning on the Leuven Affective and Pleasure Scale6 weeks
To compare changes in the functioning measure, Leuven Affective and Pleasure Scale, between the two treatment arms over the six weeks treatment period (visit 2 versus visit 4). A higher scores means worse functioning. Minimum score: 0, Maximum score: 160
SecondaryTo compare the changes in functioning on the Sheehan Disability Scale6 weeks
To compare changes in the functioning measure,Sheehan Disability Scale, between the two treatment arms over the six weeks treatment period (visit 2 versus visit 4). A higher scores means worse functioning. Minimum score: 0, maximum score 30.
SecondaryTo compare the changes in quality of life measure, Quality of Life Enjoyment and Satisfaction Questionnaire Short Form6 weeks
To compare changes in quality of life measure, Quality of Life Enjoyment and Satisfaction Questionnaire Short Form between the two treatment arms over the four weeks treatment period (visit 2 versus visit 4). A higher scores means better quality of life. Minimum score: 16, maximum score: 80.
SecondaryTo compare the changes in quality of life measure, Quality of Life Scale -100, subscale inner tension6 weeks
To compare changes in quality of life measure, Quality of Life Scale -100, subscale inner tension between the two treatment arms over the four weeks treatment period (visit 2 versus visit 4). This is a dichotomous scale (unsatisfactory or satisfactory). More 'satisfactory' answers means higher quality of life.
SecondaryTo compare the frequency of occurence of side effects between the two treatment arms.6 weeks
To compare presence of side effects as measured through General Assessment of Side Effects Scale and reported spontaneously between the two treatment arms (EIPT/TAU) over the six week treatment period (visit 2 versus visit 4). Higher scores means more side effects. Minimum score: 0 side effects, maximum score: 38 side effects.
SecondaryTo compare the proportion of participants using concomitant medication between the two treatment arms.6 weeksTo compare use of concomitant medication between the two treatment arms (EIPT/TAU) over the six week treatment period (visit 2 versus visit 4) effects.
SecondaryTo compare the proportion of participants who prematurely discontinue between the two treatment arms.6 weeksTo compare premature discontinuation between the two treatment arms (EIPT/TAU) over the six week treatment period (visit 2 versus visit 4).
SecondaryTo compare the reason of participants that prematurely discontinue the study treatment between the two treatment arms.6 weeksTo compare the difference in reasons for premature treatment discontinuation between the two treatment arms (EIPT/TAU) over the six week treatment period (visit 2 versus visit 4).
SecondaryTo compare changes in suicidal ideation between treatment arms.6 weeks.Changes on the Columbia-Suicide Severity Rating Scale (C-SSRS) throughout the study; EIPT vs TAU. Higher score means higher suicidal ideation. Max score is 5.
SecondaryTo compare occurrence of (hypo)manic episode during the study between the treatment arms6 weeks.Occurrence of (hypo)manic episodes throughout the study (including V5); EIPT vs TAU. Scores of 12 or higher means that a participant is in a (hypo)manic episode of bipolar disorder.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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