Registered outcomes11

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

1 to 11 of 11

List	Outcome	Time frame	Description
Primary	Change From Baseline to Week 12 of Calgary Depression Scale for Schizophrenia (CDSS) Score.	12 week from baseline to last visit	The CDSS scale is used to assess the level of depression in schizophrenia and to estimate the severity of depressive symptoms. CDSS has 9 items rated on four-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Anchor point descriptions are provided to aid differentiation between each item score. The first eight items are rated on basis of patients' responses to questions; the 9 item is based on clinician's assessment. The sum score is derived by adding the point score of all items (from 0 to 27 points); total score 4-5 is considered for minor depression and 6-7 score for major depression.
Secondary	Change From Baseline to Week 12 of HAM-D Score	12 weeks from baseline to last visit	21-item scale for depression. Symptoms are rated finely (on a 5-point scale: absent; doubtful or trivial; mild: moderate severe) or coarsely (on a 3- point scale: absent; doubtful or mild; obvious, distinct, or severe).Total score range 0- 66, higher values represent worse outcome.Number of participants refers to valid for efficacy per protocol. Change:total score at week 12 minus total score at baseline.
Secondary	Change From Baseline to Week 12 of PANSS Score	12 weeks from baseline to last visit	30-item scale where each symptom is rated on a severity ranging from 1-7. Symptoms are categorized into 7 items referring to positive, 7 items referring to negative and 16 general psychotic. Total score range 30- 210, higher values represent worse outcome. Number of participants analyzed refers to valid for efficacy per protocol population.
Secondary	- Change From Baseline to Week 12 of Clinical Global Impression (CGI- Severity of Illness) Score	12 weeks from baseline to last visit	The CGI-S subset ranges from 1 to 7 such that a score of 1 indicates "normal, not at all ill", while a score of 7 indicates "among the most extremely ill of patients". The change from start of treatment (baseline V2) in the Severity of Illness will be calculated by subtracting the score at start of treatment (baseline V2) from the following visits
Secondary	CGI- Global Improvement Mean Score at Week 12	12week: descriptive statistic of CGI by visit and treatment	The CGI-S subset ranges from 1 to 7 such that a score of 1 indicates "normal, not at all ill", while a score of 7 indicates "among the most extremely ill of patients". The change from start of treatment (baseline V2) in the Severity of Illness will be calculated by subtracting the score at start of treatment (baseline V2) from the following visits
Secondary	Change From Baseline to Week 12 of Drug Attitude Inventory 10 Item Scale (DAI 10) Score	12 week from baseline to last visit	These items are presented as self-report statements with which the patient agrees or disagrees. Each response is scored as +1 if correct or -1 if incorrect. The final score is the grand total of the positive and negative points. A positive score means a positive subjective response. A negative total score means a negative subjective response
Secondary	Change From Baseline in the Simpson Angus Scale (SAS) Total Score to Week 12 as an Indication of Neurological Side Effects Section	12 weeks from baseline to last visit	Extrapyramidal Side Effects (EPS) will be assessed using the Simpson-Angus Scale (SAS; Simpson GN et al 1970) . The CRF is source data for these assessments and day 0 is considered as baseline. The SAS scale, containing 10 items, will be rated on a five-point scale where 0 is normal and 4 are severe symptoms. Min score =0, max score 40 Change from start of treatment (day 0) will be calculated as the visit score minus the score at start of treatment for each of the neurological assessments.
Secondary	Concomitant Use of Antidepressive Drugs From Baseline to Week 12	12 week from baseline to last visi	Number of concomitant users of antidepressive drugs during the study; the number of participants analyzed refers to safety population, that is to overall participants excluding 6 participants who did not assume any study drug administration
Secondary	Change From Screening Visit to Week 12 of Prolactin Live	12 week from screening visit to last visit	Plasma prolactin live was drawn prior to morning meal at the screening visit at the last visit
Secondary	Body Mass Index (BMI) at Week 12	12 week	Patient weight and height have been be collected in order to assess the Body Mass Index (BMI). The mean BMI values reported are assessed after 12 weeks of treatment.
Secondary	Concomitant Use of Antidepressive Drugs From Baseline to Week 12	Change of drug use from baseline to last visi	Number of concomitant users of antidepressive drugs during the study; the number of participants analyzed refers to ITT/safety population, that is to overall participants excluding the 6 participants who did not assume any study drug administration

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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