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Trial · NCT05603104

Registered outcomes18

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

ListOutcomeTime frameDescription
PrimaryChange in symptom severity6 weeks
Change in symptom severity total score from baseline (visit 2) to end of treatment (visit 4). For Schizophrenia, this is measured using the Positive And Negative Syndrome Scale. For Major Depressive Disorder and Bipolar Depression, Montgomery Åsberg Depression Rating Scale is applied.
SecondaryAll study samples: to compare changes in the severity and improvement6 weeks
All study samples: to compare changes in the severity and improvement sub-scores of the Clinical Global Impression Scale between the two treatment arms over the six weeks treatment period (visit 2 versus visit 4).
SecondaryAll study samples: to compare changes in the levels of depression and anxiety6 weeks
All study samples: to compare changes in the levels of depression and anxiety as assessed with the Hospital Anxiety and Depression Scale bbetween the two treatment arms over the six weeks treatment period (visit 2 versus visit 4).
SecondaryAll study samples: to compare changes in cognitive performance #16 weeksAll study samples: to compare changes in cognitive performance as measured through the Trail Making Test between the two treatment arms over the six weeks treatment period (visit 2 versus visit 4).
SecondaryAll study samples: to compare changes in cognitive performance #26 weeks
All study samples: to compare changes in cognitive performance as measured through the Digit Symbol Substitution Test between the two treatment arms over four weeks (Major Depressive Disorder Group)/six weeks (Schizophrenia/Bipolar Depression groups) treatment period (visit 2 versus visit 4).
SecondaryAll study samples: to compare changes in cognitive performance #36 weeks
All study samples: 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).
SecondaryAll study samples: to compare changes in cognitive performance #46 weeks
All study samples: 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).
SecondaryAll study samples: to compare changes in functioning measure #16 weeks
All study samples: to compare changes in functioning measure (Leuven Afective and Pleasure Scale) between the two treatment arms over the four weeks (Major Depressive Disorder Group)/six weeks (Schizophrenia/Bipolar Depression groups) treatment period (visit 2 versus visit 4).
SecondaryAll study samples: to compare changes in functioning measure #26 weeks
All study samples: to compare changes in functioning measure (Sheehan Disability Scale) between the two treatment arms over the four weeks (Major Depressive Disorder Group)/six weeks (Schizophrenia/Bipolar Depression groups) treatment period (visit 2 versus visit 4).
SecondaryAll study samples: to compare changes in quality of life #16 weeks
All study samples: to compare changes in quality of life (Quality of Life Enjoyment and Satisfaction Questionnaire Short Form) between the two treatment arms over the six weeks treatment period (visit 2 versus visit 4).
SecondaryAll study samples: to compare changes in quality of life #26 weeks
All study samples: to compare changes in quality of life and functioning measures (Quality of Life Scale -100, subscale inner tension) between the two treatment arms over the six weeks treatment period (visit 2 versus visit 4).
SecondaryAll study samples: to compare presence of side effects6 weeks
All study samples: to compare presence of side effects as measured through General Assessment of Side Effect Scale between the two treatment arms over the two treatment arms over the four weeks (Major Depressive Disorder Group)/six weeks (Schizophrenia/Bipolar Depression groups) treatment period (visit 2 versus visit 4).
SecondaryAll study samples: to compare use of concomitant medication6 weeksAll study samples: to compare use of concomitant medication between the two treatment arms over the six weeks treatment period (visit 2 versus visit 4).
SecondaryAll study samples: to compare premature treatment discontinuation6 weeksAll study samples: to compare premature treatment discontinuation (timing and reason) between the two treatment arms over the six weeks treatment period (visit 2 versus visit 4).
SecondarySchizophrenia sample: to compare changes in Positive and Negative syndrome subscale scores6 weeksSchizophrenia sample: to compare changes in Positive and Negative syndrome subscale scores between the two treatment arms over the six weeks treatment period (visit 2 versus visit 4).
SecondaryAll study samples: comparison of the proportion of participants (EIPT vs. TAU) that is remission at visit 4.6 weeks
For SZ, remission is defined as meeting the PANSS modified Andreasen criteria (Low scores (≤3) P1. Delusions; P3. Hallucinatory behavior; P2. Conceptual disorganization; N1. Blunted affect; N4. Passive/apathetic social withdrawal; N6. Lack of spontaneity and flow of conversation; G5. Mannerisms/posturing; G9. Unusual thought content. For MDD/BD, remission is defined as a MADRS score ≤ 12
SecondaryAll study samples: To compare changes in suicidal ideation between treatment arms.6 weeksChanges on the Columbia-Suicide Severity Rating Scale (C-SSRS) throughout the study; EIPT vs TAU. Higher scores means higher suicidal ideation. The maximum score is 5.
SecondaryBD study sample: To compare occurrence of (hypo)manic episode during the study between the treatment arms using the Young Mania Rating Scale6 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. The minimum score on the YMRS is 0 and the maximum score 60.

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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GET https://conductscience.org/api/trials/v1/NCT05603104/registered