NCT07781293Toborzás még nem indult3. fázis
Study of Lurasidone as Adjunctive Treatment in Patients With Major Depressive Disorder With Inadequate Response to Antidepressant Monotherapy
Evaluating the Efficacy and Safety of Lurasidone as Adjunctive Therapy in Adult Patients Diagnosed With Major Depressive Disorder Who Have an Inadequate Response to Antidepressant Monotherapy: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 16.
Rövid összefoglaló (regiszter, angolul)
This Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the efficacy and safety of lurasidone as adjunctive therapy in adult patients with major depressive disorder (MDD) who show an inadequate response to antidepressant monotherapy. Eligible participants will continue their background antidepressant treatment and be randomized to receive either lurasidone (20, 40, or 60 mg/day) or placebo for 8 weeks. The primary endpoint is the change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 8. Secondary endpoints include response and remission rates, changes in Clinical Global Impression-Severity (CGI-S), 17-item Hamilton Depression Rating Scale (HAM-D17), Hamilton Anxiety Rating Scale (HAM-A), and Sheehan Disability Scale (SDS) scores. Safety assessments will include adverse events, laboratory tests, electrocardiograms (ECGs), vital signs, and suicidality monitoring Columbia-Suicide Severity Rating Scale (C-SSRS).
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- 3. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 364 (tervezett)
- Első benyújtás
- 2026. aug. 6.
- Kezdés
- 2026. szept. 28.
- Elsődleges befejezés
- 2027. okt.
- Fő szponzor
- Bukwang Pharmaceutical
- Betegségek
- Depresszió
- NCT-szám
- NCT07781293
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 3. fázis
- Tervezett résztvevők: 364
- 2026. szept. 28. és az elsődleges befejezés (2027. okt.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Prior ECT, VNS, rTMS within 5 years or history of ECT failure
- Prior exposure to lurasidone or investigational CNS drugs (per protocol limits)
- More than 2 prior attempts at screening/washout for this study
Más betegség
- Lifetime diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or other psychotic disorders
- Diagnosis within past 6 months of panic disorder, generalized anxiety disorder, OCD, PTSD, eating disorder, substance abuse/dependence (except caffeine/nicotine), or clinically significant personality disorder
- Known hypersensitivity to lurasidone or excipients
- Clinically significant uncontrolled cardiovascular, hepatic, renal, endocrine, neurological, psychiatric, or other medical conditions that may affect study participation or safety.
Laborértékek
- Use of prohibited medications (strong CYP3A4 inhibitors/inducers, QTc-prolonging drugs) within 14 days before randomization
- Clinically significant laboratory abnormalities that may affect study participation or safety.
Életkor
- First major depressive episode onset after age 60
Egyéb
- ≥25% reduction in MADRS score between screening and baseline
- Significant suicide risk (per C-SSRS, MADRS item 10 ≥5, recent suicide attempt, or investigator judgment)
- Treatment resistance: ≥3 adequate ADT trials without remission, or non-response to antipsychotic augmentation
- Pregnancy, breastfeeding, or unwillingness to use effective contraception; positive pregnancy test at screening or baseline
- Clinically significant ECG abnormalities.
- Prolactin >100 ng/mL or pituitary adenoma history
- Investigator/site staff or family members of study personnel
- Inability to comply with study procedures or anticipated relocation during study
Kiket keres a vizsgálat
- Signed informed consent prior to participation
- Outpatients aged 19-64 years
- Diagnosis of Major Depressive Disorder (MDD) per DSM-5 using MINI; psychotic features allowed
- Current major depressive episode lasting ≥8 weeks at baseline
- MADRS total score ≥24 at both screening and baseline
- CGI-S score ≥4 at both screening and baseline
- Documented history of antidepressant treatment (ADT) with inadequate response (<50% improvement)
- Currently on one of the protocol-permitted antidepressants at minimum effective dose for ≥6 weeks
- Agreement to maintain the same background ADT regimen until study completion
- BMI between 16-40 kg/m²
- Willingness to discontinue prohibited psychotropic medications during washout
- Stable doses of permitted concomitant medications (oral hypoglycemics ≥30 days, thyroid replacement ≥90 days, antihypertensives ≥30 days, lipid-lowering agents ≥30 days before baseline)
Életkor a regiszterben: 19 év – 64 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.