Clinical Trials List
Protocol NumberNBI-1065845-MDD3028
Not yet recruiting
2025-07-01 - 2030-05-31
Phase III
Recruiting4
ICD-10F32.3
Major depressive disorder, single episode, severe with psychotic features
ICD-9296.24
Major depressive disorder, single episode, severe specified as with psychotic behavior
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Maintenance of Effect of NBI-1065845 as an Adjunctive Treatment in Subjects with Major Depressive Disorder (MDD)
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
Neurocrine Biosciences, Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Ya-Mei Bai Division of Psychiatry
- 鄭智銘 Division of Psychiatry
- 胡力予 Division of Psychiatry
- 鄭佳洵 Division of Psychiatry
- 黃翔瑄
- Cheng-Ta Li Division of Psychiatry
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Kuo-Hsuan Chung
Co-Principal Investigator
- HSIN-CHIEN LEE Division of Psychiatry
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Depressive Disorder (MDD)
Objectives
To evaluate the efficacy of NBI‑1065845 compared with placebo as an adjunctive treatment in
delaying relapse of depressive symptoms (maintenance of effect) in subjects with MDD who
have a stable response after open-label treatment with NBI‑1065845.
Test Drug
tablet
Active Ingredient
NBI-1065845
Dosage Form
110
Dosage
1 mg per tablet
Endpoints
The primary endpoint for this study will be the time from randomization to relapse.
Inclution Criteria
Subjects must meet all of the following inclusion criteria:
1. Completed informed consent.
2. ≥18 years of age at the time of signing the informed consent.
3. A body mass index (BMI) of 18 to 42 kg/m2, inclusive (BMI is defined as the subject's
weight in kilograms divided by the square of the subject's height in meters).
4. The subject has a primary diagnosis of recurrent MDD (moderate or severe) or persistent
depressive disorder meeting the Diagnostic and Statistical Manual of Mental Disorders,
5th Edition (DSM-5) criteria or relevant International Statistical Classification of Diseases
and Related Health Problems, 10th Revision (ICD-10) criteria codes for 296.32 (F33.1),
296.33 (F33.2), 296.35 (F33.41), or 300.4 (F34.1). The diagnosis must be confirmed using
the Mini-International Neuropsychiatric Interview (MINI) in a face-to-face evaluation.
5. The subject must be receiving ≥1 oral antidepressant treatment(s) (listed in Appendix B) and
must:
• Have been taking their current antidepressant medication(s) for ≥8 weeks prior to
screening, AND
• Be willing to continue the same treatment at the same dose and frequency of
administration throughout participation in the study, AND
• Antidepressant treatment(s) must be confirmed by records/documentation consistent
with site or local practice (eg, medical, prescription, or pharmacy records, or health
insurance data).
6. Subject must have an IR (≤50% improvement) to 1 to 5 (inclusive) oral antidepressant
treatments (including the subject’s current antidepressant treatment) that were administered
as adequate courses (dose, duration, adherence) in the current episode of depression, as
assessed using the Massachusetts General Hospital - Antidepressant Treatment Response
Questionnaire (MGH-ATRQ).
7. Total Hamilton Depression Rating Scale-17 Item (HAM-D17) score ≥22 at screening and at
study baseline (Day 1).
8. The subject’s current major depressive episode, depression symptom severity, and
antidepressant treatment response in the current depressive episode must be confirmed by the
“State versus Trait, Assessability, Face Validity, Ecological Validity, Rule of Three P’s”
(SAFER) Interview and final agreement with the Sponsor or Sponsor designee.
9. All subjects who are receiving psychotherapy (including cognitive behavioral therapy [CBT])
can continue receiving psychotherapy; however, CBT must have been ongoing for the last
3 months prior to Day 1. New psychotherapy may not be initiated during this study.
10. The subject is euthyroid. An abnormally high or low thyroid-stimulating hormone (TSH)
level may be corroborated by a free thyroxine (T4) level in addition to a comprehensive
history and physical examination to rule out a thyroid disorder. Subjects maintained on
thyroid medication must be on stable dosage for a period of ≥3 months prior to the screening
visit.
11. Negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test at screening and a
negative urine pregnancy test at Day 1, for females of childbearing potential.
12. Female subjects of childbearing potential must agree to use acceptable methods of
contraception as listed below consistently from screening until the final study visit or 30 days
after the last dose of study treatment, whichever is longer.
Women are considered to not be of childbearing potential if they are either postmenopausal
(defined as no menses for 12 months without an alternative medical cause and confirmed by
elevated follicle stimulating hormone (FSH) consistent with a postmenopausal range) or if
they have undergone permanent sterilization procedure, such as hysterectomy, bilateral
salpingectomy, or bilateral oophorectomy.
Acceptable methods of contraception include the following:
• Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)
• Combined (estrogen and progestogen containing) hormonal contraception associated
with inhibition of ovulation, which may be oral, intravaginal, or transdermal at least
3 months prior to screening
• Progestogen-only hormonal contraception associated with inhibition of ovulation,
which may be oral, injected, or implanted at least 3 months prior to screening
• Bilateral tubal ligation
• Total abstinence from heterosexual intercourse (periodic abstinence is not acceptable)
• Sexual partner(s) who had been vasectomized for at least 3 months prior to screening
with medically confirmed successful procedure
• Progesterone only where inhibition of ovulation is not the primary mode of action
• Male or female condom with or without spermicide
• Cap, diaphragm, or sponge with spermicide
13. Willing and able to comply with all study procedures and restrictions in the opinion of the
investigator.
1. Completed informed consent.
2. ≥18 years of age at the time of signing the informed consent.
3. A body mass index (BMI) of 18 to 42 kg/m2, inclusive (BMI is defined as the subject's
weight in kilograms divided by the square of the subject's height in meters).
4. The subject has a primary diagnosis of recurrent MDD (moderate or severe) or persistent
depressive disorder meeting the Diagnostic and Statistical Manual of Mental Disorders,
5th Edition (DSM-5) criteria or relevant International Statistical Classification of Diseases
and Related Health Problems, 10th Revision (ICD-10) criteria codes for 296.32 (F33.1),
296.33 (F33.2), 296.35 (F33.41), or 300.4 (F34.1). The diagnosis must be confirmed using
the Mini-International Neuropsychiatric Interview (MINI) in a face-to-face evaluation.
5. The subject must be receiving ≥1 oral antidepressant treatment(s) (listed in Appendix B) and
must:
• Have been taking their current antidepressant medication(s) for ≥8 weeks prior to
screening, AND
• Be willing to continue the same treatment at the same dose and frequency of
administration throughout participation in the study, AND
• Antidepressant treatment(s) must be confirmed by records/documentation consistent
with site or local practice (eg, medical, prescription, or pharmacy records, or health
insurance data).
6. Subject must have an IR (≤50% improvement) to 1 to 5 (inclusive) oral antidepressant
treatments (including the subject’s current antidepressant treatment) that were administered
as adequate courses (dose, duration, adherence) in the current episode of depression, as
assessed using the Massachusetts General Hospital - Antidepressant Treatment Response
Questionnaire (MGH-ATRQ).
7. Total Hamilton Depression Rating Scale-17 Item (HAM-D17) score ≥22 at screening and at
study baseline (Day 1).
8. The subject’s current major depressive episode, depression symptom severity, and
antidepressant treatment response in the current depressive episode must be confirmed by the
“State versus Trait, Assessability, Face Validity, Ecological Validity, Rule of Three P’s”
(SAFER) Interview and final agreement with the Sponsor or Sponsor designee.
9. All subjects who are receiving psychotherapy (including cognitive behavioral therapy [CBT])
can continue receiving psychotherapy; however, CBT must have been ongoing for the last
3 months prior to Day 1. New psychotherapy may not be initiated during this study.
10. The subject is euthyroid. An abnormally high or low thyroid-stimulating hormone (TSH)
level may be corroborated by a free thyroxine (T4) level in addition to a comprehensive
history and physical examination to rule out a thyroid disorder. Subjects maintained on
thyroid medication must be on stable dosage for a period of ≥3 months prior to the screening
visit.
11. Negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test at screening and a
negative urine pregnancy test at Day 1, for females of childbearing potential.
12. Female subjects of childbearing potential must agree to use acceptable methods of
contraception as listed below consistently from screening until the final study visit or 30 days
after the last dose of study treatment, whichever is longer.
Women are considered to not be of childbearing potential if they are either postmenopausal
(defined as no menses for 12 months without an alternative medical cause and confirmed by
elevated follicle stimulating hormone (FSH) consistent with a postmenopausal range) or if
they have undergone permanent sterilization procedure, such as hysterectomy, bilateral
salpingectomy, or bilateral oophorectomy.
Acceptable methods of contraception include the following:
• Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)
• Combined (estrogen and progestogen containing) hormonal contraception associated
with inhibition of ovulation, which may be oral, intravaginal, or transdermal at least
3 months prior to screening
• Progestogen-only hormonal contraception associated with inhibition of ovulation,
which may be oral, injected, or implanted at least 3 months prior to screening
• Bilateral tubal ligation
• Total abstinence from heterosexual intercourse (periodic abstinence is not acceptable)
• Sexual partner(s) who had been vasectomized for at least 3 months prior to screening
with medically confirmed successful procedure
• Progesterone only where inhibition of ovulation is not the primary mode of action
• Male or female condom with or without spermicide
• Cap, diaphragm, or sponge with spermicide
13. Willing and able to comply with all study procedures and restrictions in the opinion of the
investigator.
Exclusion Criteria
Subjects will be excluded from the study if they meet any of the following criteria:
Psychiatric Criteria:
1. A current or prior psychiatric disorder diagnosis in the last 1 year that was the primary focus
of treatment other than MDD (assessed by the MINI); a comorbid personality disorder that
has been evident outside of depressive episodes or that may interfere with participation in the
study; or a diagnosis of neurodegenerative disorders (including but not limited to dementias),
eating disorder, schizophrenia, schizoaffective disorder, bipolar disorder, MDD with
psychotic features or mixed features, intellectual disability, or mental disorders due to a
general medical condition as defined in DSM-5.
2. Are considered by the investigator to be at imminent risk of suicide or injury to self or others:
• Have a significant risk of suicidal or violent behavior, or attempted suicide in the
1 year prior to screening.
• Subjects with any suicidal ideation of type 4 (active suicidal ideation with some intent
to act, without specific plan) or type 5 (active suicidal ideation with specific plan and
intent) in the past 6 months before screening based on the C-SSRS.
• According to the investigator's clinical judgment should be excluded.
3. Subject has moderate-to-severe substance use disorder diagnosis per DSM-5 with the
exception of caffeine, nicotine, and cannabis (see below) or has a known drug dependence
within 12 months of the start of screening:
• The subject has a positive urine drug screen (UDS) at screening or Day 1 for
disallowed substances (eg, alcohol, barbiturates, phencyclidine, cocaine, opiates,
amphetamines, methadone, or unprescribed benzodiazepines).
• The subject is taking a daily dose of a prescription benzodiazepine greater than the
equivalent of 4 mg/day of lorazepam (Appendix C).
Note: Subjects testing positive for cannabinoids at screening may be eligible for participation
in the study if all of the following criteria are met:
• The subject does not meet the diagnostic criteria for moderate or severe substance use
disorder within the 12 months before screening based on the MINI.
• Based on the investigator’s clinical assessment, the subject’s cannabis use is limited
to ≤3 times per week and is not expected to interfere with their ability to adhere to
study procedures.
• Cannabis is legal per local law.
Psychiatric Criteria:
1. A current or prior psychiatric disorder diagnosis in the last 1 year that was the primary focus
of treatment other than MDD (assessed by the MINI); a comorbid personality disorder that
has been evident outside of depressive episodes or that may interfere with participation in the
study; or a diagnosis of neurodegenerative disorders (including but not limited to dementias),
eating disorder, schizophrenia, schizoaffective disorder, bipolar disorder, MDD with
psychotic features or mixed features, intellectual disability, or mental disorders due to a
general medical condition as defined in DSM-5.
2. Are considered by the investigator to be at imminent risk of suicide or injury to self or others:
• Have a significant risk of suicidal or violent behavior, or attempted suicide in the
1 year prior to screening.
• Subjects with any suicidal ideation of type 4 (active suicidal ideation with some intent
to act, without specific plan) or type 5 (active suicidal ideation with specific plan and
intent) in the past 6 months before screening based on the C-SSRS.
• According to the investigator's clinical judgment should be excluded.
3. Subject has moderate-to-severe substance use disorder diagnosis per DSM-5 with the
exception of caffeine, nicotine, and cannabis (see below) or has a known drug dependence
within 12 months of the start of screening:
• The subject has a positive urine drug screen (UDS) at screening or Day 1 for
disallowed substances (eg, alcohol, barbiturates, phencyclidine, cocaine, opiates,
amphetamines, methadone, or unprescribed benzodiazepines).
• The subject is taking a daily dose of a prescription benzodiazepine greater than the
equivalent of 4 mg/day of lorazepam (Appendix C).
Note: Subjects testing positive for cannabinoids at screening may be eligible for participation
in the study if all of the following criteria are met:
• The subject does not meet the diagnostic criteria for moderate or severe substance use
disorder within the 12 months before screening based on the MINI.
• Based on the investigator’s clinical assessment, the subject’s cannabis use is limited
to ≤3 times per week and is not expected to interfere with their ability to adhere to
study procedures.
• Cannabis is legal per local law.
The Estimated Number of Participants
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Taiwan
7 participants
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Global
600 participants
