Trial · NCT07573176
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Double Blind (DB) Treatment Phase: Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score in Participants with Major Depressive Disorder with Moderate-to-Severe Insomnia Symptoms (MDDIS) | Baseline up to Day 43 | The MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition. |
| Primary | Open-Label (OL) Treatment Phase: Number of Participants with Adverse Events Including Adverse Event of Special Interests (AESIs) | OL Baseline (Day 43) Up to 6 months | An AE is any untoward medical occurrence in a clinical study participant administered with a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. The following AESIs are considered in this study: Suicidal thoughts, suicidal ideation, and suicidal behavior; Cataplexy; Sleep paralysis; Complex, sleep-related behaviors/parasomnias; Fall and Motor vehicle accident. |
| Primary | OL Treatment Phase: Number of Participants with Vital Signs Abnormalities | OL Baseline (Day 43) Up to 6 months | Number of participants with vital signs (blood pressure and pulse/heart rate measurements) abnormalities will be reported. |
| Primary | OL Treatment Phase: Number of Participants with Suicidality Assessment using Columbia-Suicide Severity Rating Scale (C-SSRS) | OL Baseline (Day 43) Up to 6 months | The C-SSRS is a low-burden measure of the spectrum of suicidal ideation and behavior that was developed to assess severity and track suicidal events through any treatment. The C-SSRS scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. Suicidal ideation consists of 5 'yes/no' items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent. |
| Primary | OL Treatment Phase: Number of Participants with Withdrawal Symptoms Assessment Using Physician Withdrawal Checklist (PWC-20) | End of Treatment/Early withdrawal to end of the Follow-up visit (up to 14 days) | Potential withdrawal effects will be assessed by the PWC-20. The PWC-20 is a simple and accurate method used to assess potential withdrawal symptoms following cessation of treatment. The PWC-20 is a reliable and sensitive instrument for the assessment of discontinuation symptoms. |
| Primary | OL Treatment Phase: Number of Participants with Abnormalities in Electrocardiogram (ECG) | OL Baseline (Day 43) up to 6 months | Number of participants with abnormalities in ECG will be reported. |
| Primary | OL Treatment Phase: Number of Participants Reporting Sexual Functioning using Arizona Sexual Experiences Scale (ASEX) | Up to 6 months | The ASEX is a patient-reported 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction. The scale has shown satisfactory reliability and validity. |
| Primary | OL Treatment Phase: Change from Baseline in the Body Weight | OL Baseline (Day 43) up to 6 months | Change from baseline in body weight will be reported. |
| Primary | OL Treatment Phase: Change from Baseline in the Body Mass Index (BMI) | OL Baseline (Day 43) up to 6 months | Change from baseline in BMI will be reported. |
| Primary | OL Treatment Phase: Change from Baseline in the Waist Circumference | OL Baseline (Day 43) up to 6 months | Change from baseline in waist circumference will be reported. |
| Primary | OL Treatment Phase: Number of Participants with Abnormalities in Clinical Laboratory Parameters | OL Baseline (Day 43) up to 6 months | Number of participants with laboratory abnormalities related to hematology, serum chemistry will be reported. |
| Secondary | DB Treatment Phase: Change from Baseline in MADRS-Without Sleep Item (WOSI) Total Score | Baseline up to Day 43 | MADRS-WOSI considered 9 of the 10 MADRS items, excluding "reduced sleep" item. The total score ranged from 0 to 54, with higher scores corresponding to greater symptom severity. |
| Secondary | DB Treatment Phase: Change from Baseline in Sleep Disturbance using Patient Reported Outcome Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form 10a(8a + 2a ) T-score | Baseline up to Day 43 | The PROMIS-SD is used to assess self-reported perceptions of sleep quality, sleep depth and restoration associated with sleep. The full PROMIS-SD includes 27 items with each item based on a 7-day recall period and assessed on a 5 level Likert-type scale. The 10-item short form will be used, in which responses are scored 1 to 5 for each item. T-score for the PROMIS-SD scales represent the value obtained after using a conversion table to convert the total raw score. To find the total raw score for a short form with all questions answered, sum the values of the response to each question. For example, for the adult 10-item form, the lowest possible raw score is 10; the highest possible raw score is 50. Higher overall score indicates more sleep disturbance. |
| Secondary | DB Treatment phase: Change from Baseline in MADRS-6 Total Score | Baseline up to Day 43 | The MADRS-6 scale is a clinician-administered questionnaire used to measure the severity of major depressive disorder (MDD) symptoms. The MADRS-6 scale is a subset of the MADRS -10 scale, comprised of the following individual questionnaire items: apparent sadness, reported sadness, inner tension, lassitude, inability to feel, and pessimistic thoughts. Scores range from 0 (no apparent symptoms) to 36 (most severe symptoms). |
| Secondary | DB Treatment Phase: Proportion of Participants with Response on Depressive Symptoms Scale | Baseline up to Day 43 | Responders are defined as proportion of participants with greater than or equal to (\>=) 50 percent (%) improvement in the MADRS total score from baseline to Day 43. |
| Secondary | DB Treatment Phase: Change from Baseline in Sleep Disturbance using PROMIS-SD Short Form 8a T-Score | Baseline up to Day 43 | The PROMIS-SD is used to assess self-reported perceptions of sleep quality, sleep depth and restoration associated with sleep. The full PROMIS-SD includes 27 items with each item based on a 7-day recall period and assessed on a 5 level Likert-type scale. The 8-item short form will be used in this study, in which responses are scored 1 to 5 for each item. T-score for the PROMIS-SD scales represent the value obtained after using a conversion table to convert the total raw score. To find the total raw score for a short form with all questions answered, sum the values of the response to each question. For example, for the adult 8-item form, the lowest possible raw score is 8; the highest possible raw score is 40. Higher overall score indicates more sleep disturbance. |
| Secondary | DB Treatment Phase: Change from Baseline in Patient Health Questionnaire 9-Item (PHQ-9) Total Score | Baseline up to Day 43 | The PHQ-9 is a 9-item, participant reported outcome measure to assess depressive symptoms. The scale scores each of the 9 symptom domains of the DSM-5 MDD criteria. Each item is rated on a 4 point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms. |
| Secondary | DB Period: Change from Baseline in Work Productivity and Activity Impairment Questionnaire, Depression (WPAI-D) Scores | Baseline up to Day 43 | The WPAI-D questionnaire is a patient-reported instrument to measure impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problems during the past 7 days. The WPAI yields four types of scores: (a) Absenteeism (work time missed); (b) Presenteeism (impairment at work / reduced on-the-job effectiveness); (c) Work productivity loss (overall work impairment / absenteeism plus presenteeism); (d) Activity Impairment. The first three scores are derived only for respondents who were working (should be missing for non-working), but the last score is applicable for all respondents. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity. Negative changes in score indicates less impairment and greater productivity. |
| Secondary | OL Treatment Phase: Change from Baseline Over Time in MADRS Total Score | OL Baseline (Day 43) up to 6 months | The MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition. |
| Secondary | OL Treatment Phase: Change from Baseline Over Time in Clinical Global Impression-Severity (CGI-S) Score | OL Baseline (Day 43) up to 6 months | The CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness that takes into account all available information, including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-S evaluates the severity of psychopathology on a scale of 1 to 7. Considering total clinical experience with the depression population, a participant is assessed on severity of illness at the time of rating according to the following criteria: 1=normal (not at all ill); 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. |
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.
For software
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GET https://conductscience.org/api/trials/v1/NCT07573176/registered