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3111-302-001- Move to Production

Status & Metadata
Source Method : Publicly Available
Source URL: Link
Generation Method : Unknown
Date Added: 16 Jun 2026
Contributor: System
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Additional Resources
Protocol
Date Added: 16 Jun 2026
CDISC CORE Conformance
Conformance assessed
SKIPPED 53
SUCCESS 139
ISSUE_REPORTED 10
EXECUTION_ERROR 5
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Rationale

A Double-Blind, Placebo-Controlled Study of Cariprazine as an Adjunct to Antidepressants in the Treatment of Patients With Major Depressive Disorder who Have had an Inadequate Response to Antidepressants Alone

Key Metrics

Interventional Study
Phase III Trial
1.0
0c9c7a47-127f-4bc2-8f53-09973dd60b4f

Important Dates

Event Date
Protocol Approval 01 Jan 2024

Schedule of Activities: Main Study Design

Timeline: Main
Visit / Timing Interval Window Activities
Treatment Day 1.0
TIM1 		1 day No window
  • Informed Consent Obtained
  • Verified Clinical Trials (VCT) Check
  • Medical History, General (Lifetime)
  • Medical History, Relevant
  • Concomitant Medications
  • Inclusion/Exclusion Criteria
  • Informed Consent, Optional Sample Collection (Pharmacogenetic)
  • Vital Signs
  • Complete Physical Exam
  • Columbia-Suicide Severity Rating Scale, Lifetime (C-SSRS)
  • Montgomery-Asberg Depression Rating Scale (MADRS)
  • Young Mania Rating Scale (YMRS)
  • Antidepressant Treatment Response Questionnaire (ATRQ), ClinRO
  • SAFER Criteria Inventory
  • SAFER Score Evaluation
  • Structured Clinical Interview for DSM-5 Axis I Disorders (SCID-5)
  • Adverse Events
  • Human Chorionic Gonadotropin (HCG) Beta Subunit (Pregnancy Test) [Presence]
  • HBV and HCV Screening and Diagnosis, Ser/Plas
  • Hemoglobin A1c (HbA1c) [Mass/Vol], Bld
  • Alcohol Breath Test
  • CBC W Differential Panel (Automated), Bld
  • Chemistry Panel (CHEM-20), Ser/Plas
  • Urinalysis Dipstick w Reflex Microscopic Panel
  • Drug Identification by Screen Method, Urine
  • Myoglobin [Presence], Urine
  • Thyroid Function Panel (TSH/FT3/FT4), Ser/Plas
  • Lipid Panel, Ser/Plas
  • Prior Medications
  • Bilirubin Direct [Mass/Vol]
  • Bilirubin Indirect [Mass/Vol]
  • Lactate Dehydrogenase [Act/Vol]
  • Creatine Kinase [Act/Vol]
  • Prolactin [Mass/Vol]
  • Insulin [Mass/Vol]
  • Magnesium [Mass/Vol]
  • 12 Lead ECG
  • Hamilton Depression Rating Scale (HDRS-17)
  • Clinical Global Impression of Severity (CGI-S)
Treatment Day 8.0
TIM2 		1 day No window
  • Informed Consent Obtained
  • Vital Signs
  • IRT-Randomization
  • SAFER Score Evaluation
  • Young Mania Rating Scale (YMRS)
  • Montgomery-Asberg Depression Rating Scale (MADRS)
  • Medication Compliance Assessment
  • Concomitant Medications
  • Investigational Product Dispensation
  • Adverse Events
  • 12-Item Short Form Survey (SF-12)
  • Barnes Akathisia Rating Scale (BARS)
  • Abnormal Involuntary Movement Scale (AIMS)
  • Simpson Angus Scale (SAS)
  • Pharmacogenetic DNA Analysis Panel, Bld/Tiss
  • Informed Consent, Optional Sample Collection (Pharmacogenetic)
  • Columbia-Suicide Severity Rating Scale, Since Last Visit (C-SSRS)
  • IP Administration - Oral Capsule
  • Non-IP Administration - Oral Capsule
  • Hamilton Depression Rating Scale (HDRS-17)
  • Clinical Global Impression of Severity (CGI-S)
  • Hamilton Anxiety Rating Scale (HAM-A)
Treatment Day 15.0
TIM3 		1 day No window
  • Barnes Akathisia Rating Scale (BARS)
  • Abnormal Involuntary Movement Scale (AIMS)
  • Simpson Angus Scale (SAS)
  • Concomitant Medications
  • Adverse Events
  • Medication Compliance Assessment
  • Investigational Product Dispensation
  • Investigational Product Return
  • Investigational Product Compliance Assessment
  • Pharmacogenetic DNA Analysis Panel, Bld/Tiss
  • Informed Consent, Optional Sample Collection (Pharmacogenetic)
  • Vital Signs
  • Young Mania Rating Scale (YMRS)
  • Montgomery-Asberg Depression Rating Scale (MADRS)
  • Columbia-Suicide Severity Rating Scale, Since Last Visit (C-SSRS)
  • IP Administration - Oral Capsule
  • Non-IP Administration - Oral Capsule
  • Clinical Global Impression of Severity (CGI-S)
  • Clinical Global Impression of Improvement (CGI-I)
Treatment Day 29.0
TIM4 		1 day No window
  • Montgomery-Asberg Depression Rating Scale (MADRS)
  • Vital Signs
  • Barnes Akathisia Rating Scale (BARS)
  • Abnormal Involuntary Movement Scale (AIMS)
  • Simpson Angus Scale (SAS)
  • Pharmacogenetic DNA Analysis Panel, Bld/Tiss
  • PK Sampling, Bld
  • Informed Consent, Optional Sample Collection (Pharmacogenetic)
  • Investigational Product Dispensation
  • Investigational Product Return
  • Investigational Product Compliance Assessment
  • Medication Compliance Assessment
  • Adverse Events
  • Concomitant Medications
  • Columbia-Suicide Severity Rating Scale, Since Last Visit (C-SSRS)
  • IP Administration - Oral Capsule
  • Non-IP Administration - Oral Capsule
  • Clinical Global Impression of Severity (CGI-S)
  • Clinical Global Impression of Improvement (CGI-I)
  • Hamilton Anxiety Rating Scale (HAM-A)
Treatment Day 42.0
TIM5 		1 day No window
  • Montgomery-Asberg Depression Rating Scale (MADRS)
  • Vital Signs
  • Barnes Akathisia Rating Scale (BARS)
  • Abnormal Involuntary Movement Scale (AIMS)
  • Simpson Angus Scale (SAS)
  • Pharmacogenetic DNA Analysis Panel, Bld/Tiss
  • PK Sampling, Bld
  • Informed Consent, Optional Sample Collection (Pharmacogenetic)
  • Investigational Product Dispensation
  • Investigational Product Return
  • Investigational Product Compliance Assessment
  • Medication Compliance Assessment
  • Adverse Events
  • Concomitant Medications
  • Columbia-Suicide Severity Rating Scale, Since Last Visit (C-SSRS)
  • IP Administration - Oral Capsule
  • Non-IP Administration - Oral Capsule
  • Clinical Global Impression of Severity (CGI-S)
  • Clinical Global Impression of Improvement (CGI-I)
Follow Up Day 28.0
TIM6 		1 day No window
  • Adverse Events
  • Pharmacogenetic DNA Analysis Panel, Bld/Tiss
  • PK Sampling, Bld
  • Concomitant Medications
  • 12-Item Short Form Survey (SF-12)
  • Barnes Akathisia Rating Scale (BARS)
  • Abnormal Involuntary Movement Scale (AIMS)
  • Simpson Angus Scale (SAS)
  • Investigational Product Return
  • Investigational Product Compliance Assessment
  • Medication Compliance Assessment
  • Informed Consent, Optional Sample Collection (Pharmacogenetic)
  • Vital Signs
  • CBC W Differential Panel (Automated), Bld
  • Chemistry Panel (CHEM-20), Ser/Plas
  • Urinalysis Dipstick w Reflex Microscopic Panel
  • Human Chorionic Gonadotropin (HCG) Beta Subunit (Pregnancy Test) [Presence]
  • Complete Physical Exam
  • Lipid Panel, Ser/Plas
  • Bilirubin Direct [Mass/Vol]
  • Bilirubin Indirect [Mass/Vol]
  • Thyroid Function Panel (TSH/FT3/FT4), Ser/Plas
  • Lactate Dehydrogenase [Act/Vol]
  • Creatine Kinase [Act/Vol]
  • Prolactin [Mass/Vol]
  • Insulin [Mass/Vol]
  • Magnesium [Mass/Vol]
  • 12 Lead ECG
  • Columbia-Suicide Severity Rating Scale, Since Last Visit (C-SSRS)
  • IP Administration - Oral Capsule
  • Non-IP Administration - Oral Capsule
  • Hamilton Depression Rating Scale (HDRS-17)
  • Clinical Global Impression of Severity (CGI-S)
  • Clinical Global Impression of Improvement (CGI-I)
  • Hamilton Anxiety Rating Scale (HAM-A)
Follow Up Day 28.0
TIM7 		1 day No window
  • Adverse Events
  • Pharmacogenetic DNA Analysis Panel, Bld/Tiss
  • PK Sampling, Bld
  • Concomitant Medications
  • 12-Item Short Form Survey (SF-12)
  • Barnes Akathisia Rating Scale (BARS)
  • Abnormal Involuntary Movement Scale (AIMS)
  • Simpson Angus Scale (SAS)
  • Investigational Product Return
  • Investigational Product Compliance Assessment
  • Medication Compliance Assessment
  • Informed Consent, Optional Sample Collection (Pharmacogenetic)
  • Vital Signs
  • CBC W Differential Panel (Automated), Bld
  • Chemistry Panel (CHEM-20), Ser/Plas
  • Urinalysis Dipstick w Reflex Microscopic Panel
  • Human Chorionic Gonadotropin (HCG) Beta Subunit (Pregnancy Test) [Presence]
  • Complete Physical Exam
  • Lipid Panel, Ser/Plas
  • Bilirubin Direct [Mass/Vol]
  • Bilirubin Indirect [Mass/Vol]
  • Thyroid Function Panel (TSH/FT3/FT4), Ser/Plas
  • Lactate Dehydrogenase [Act/Vol]
  • Creatine Kinase [Act/Vol]
  • Prolactin [Mass/Vol]
  • Insulin [Mass/Vol]
  • Magnesium [Mass/Vol]
  • 12 Lead ECG
  • Columbia-Suicide Severity Rating Scale, Since Last Visit (C-SSRS)
  • IP Administration - Oral Capsule
  • Non-IP Administration - Oral Capsule
  • Hamilton Depression Rating Scale (HDRS-17)
  • Clinical Global Impression of Severity (CGI-S)
  • Clinical Global Impression of Improvement (CGI-I)
  • Hamilton Anxiety Rating Scale (HAM-A)