A Phase II Study to Evaluate NH102 for Depression

Korábbi kezelés

• Substance abuse within the past year or positive at screening drug test.
• Previous treatment with duloxetine without adequate response.
• Normative use of antidepressants within 2 weeks prior to screening.
• Use of CYP2D6 or CYP1A2 potent inhibitors/inducers within 2 weeks prior to screening.

Más betegség

• Treatment-resistant depression (failure of ≥ 2 adequate antidepressant treatments).
• Other psychiatric disorders (e.g., schizophrenia, bipolar disorder, anxiety disorders).
• History of severe neurological diseases, epilepsy, or significant head trauma.
• Unstable or severe cardiovascular, gastrointestinal, or endocrine diseases.
• History of malignancy within the past 2 years.
• History of increased intraocular pressure or untreated narrow-angle glaucoma.
• History of severe drug allergies or hypersensitivity to duloxetine or excipients.
• Any condition deemed unsuitable by the investigator.

Egyéb

• Duration of the current depressive episode in first-episode patients < 3 months.
• Abnormal thyroid function not adequately controlled.
• Suicide attempt within the past year or significant suicide risk.
• Alcohol abuse (≥ 14 units/week) within the past year.
• Participation in another clinical trial within the past 3 months.

• Male and female outpatients aged 18-65 years (inclusive).
• Diagnosis of Major Depressive Disorder (MDD) according to DSM-5 criteria ( without psychotic features).
• Hamilton Depression Rating Scale (HAM-D17) total score ≥ 22 at screening and baseline visits, with item 1 (depressed mood) score ≥ 2.
• Clinical Global Impression-Severity (CGI-S) score ≥ 4 at screening and baseline.
• Negative pregnancy test for women of childbearing potential.
• Willingness to use effective contraception during the trial and for 3 months after the last dose.
• Voluntary participation and signed informed consent.