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Dose-Finding Clinical Trial to Evaluate the Efficacy and Safety of LV232 Capsules in the Treatment of MDD

ConditionMDD
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVigonvita Life Sciences

About this trial

This multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-finding Phase II clinical trial aimed to determine the optimal dose of LV232 capsules for treating MDD, evaluate preliminary efficacy and safety, and provide a basis for Phase III trial design and dosing regimen determination.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Fully understand the purpose, content, and potential adverse reactions of this trial, voluntarily participate in the clinical trial and sign a written informed consent form, able to complete the entire trial process as required and comply with the trial regulations;

Gender unrestricted, at screening: 18 years old ≤ age ≤ 65 years old;

Meet the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) diagnostic criteria for depression according to the Mini International Neuropsychiatric Interview (M.I.N.I. 7.0.2), currently experiencing a single or multiple episodes;

For first-episode patients, the duration of the current depressive episode must be ≥3 months; for recurrent patients, the duration of the current depressive episode must be ≥1 month (each month is counted as 30 days, the same applies below);

Disqualifiers

Treatment-resistant depression (failure to respond to an adequate dose and duration of treatment, at least 8 weeks, with two antidepressants of different mechanisms) or failure to respond to an adequate dose and duration of treatment with escitalopram oxalate;

Meeting the diagnostic criteria for other mental disorders as per DSM-5 (such as schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, generalized anxiety disorder, obsessive-compulsive and related disorders, somatic symptom and related disorders, etc.);

Meeting the DSM-5 criteria for substance use disorder;

Organic mental disorders, such as depression caused by hypothyroidism;

Trial design

Design model

Parallel

Treatments tested in this trial

  • LV232 40mg

    Drug

    LV232 capsules 2 capsules (20 mg/capsule) + LV232 capsule placebo 1 capsule + escitalopram oxalate tablet placebo 1 tablet

  • LV232 60mg

    Drug

    LV232 capsules 3 capsules (20 mg/capsule) + escitalopram oxalate tablet placebo 1 tablet

  • Escitalopram

    Drug

    LV232 capsule placebo 3 capsule + escitalopram oxalate tablet 1 tablet

  • Placebo

    Drug

    LV232 capsule placebo 3 capsule + escitalopram oxalate tablet placebo 1 tablet

Treatment groups

400 Participants
are divided into 3 treatment groups
Group A: LV232 capsulesExperimental treatment 2 interventions
Group B: EscitalopramActive comparator 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in Montgomery Asperger Depression Scale (MADRS) score at the end of treatment (week 8)

The MADRS is a clinician-rated scale used to evaluate depressive symptoms over the preceding week. Participants are assessed on 10 items-including feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest-each scored on a 7-point scale (0 = no symptoms, 6 = maximum severity). The total score ranges from 0 to 60, with higher scores indicating greater depression severity. A negative change in score signifies improvement. Change = (Week 8 post-dose score - baseline week 0 score). at the end of treatment (week 8)

Time frame
Baseline and week 8

Secondary outcomes

1

Change from baseline in Hamilton Depression Scale (HAMD-17) at week 8

The HAMD-17 is a 17-item, clinician-rated scale that assesses depressive symptoms. The HAMD-17 consists of 17 symptoms, each of which is rated from 0 to 2 or 0 to 4, where 0 is none/absent. The HAMD-17 total score is calculated as the sum of the 17 individual symptom scores; the total score can range from 0 to 52. Higher HAMD-17 scores indicate more severe depression. Change = (Week 8 post-dose score - baseline week 0 score).

Time frame
Baseline, week 8
2

Change from baseline in Hamilton Anxiety Inventory (HAMA) scores at week 8

The HAMA is used as a rating measure of anxiety severity. The scale consists of 14 items. Each item is rated on a scale of 0 to 4. The HAMA total score is the sum of the 14 items and the score ranges from 0 to 56, 0 is considered the best outcome. Change = (Week 8 post-dose score - baseline week 0 score).

Time frame
Baseline, week 8
3

Change from baseline in CGI-S score at week 8

The CGI-S is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment. The CGI-S will provide an overall clinician-determined summary measure 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. Change = (Week 8 post-dose score - baseline week 0 score).

Time frame
Baseline and week 8
4

CGI-I score at week 8

The CGI-I assesses the subject's improvement (or worsening). The rater is required to assess the subject's condition relative to baseline\* on a 7-point scale. In all cases, the assessment should be made independent of whether the rater believes the improvement is study medication-related or not.

Time frame
Baseline, week 8

Other outcomes

Sponsors and contacts

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Vigonvita Life Sciences

Lead sponsor

Source ClinicalTrials.gov
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