Clinical TrialChronic PainPlaceboEsketamineEsketamineEsketamineUnknown status

Esketamine Adjuvant Therapy for Patients With Chronic Visceral Pain Comorbid Major Depressive Disorder

Therefore, this study aims to explore the difference in the efficacy and safety of esketamine as an adjuvant therapy and positive control drug-pregabalin in patients with chronic visceral pain comorbid depression.

Target Enrollment
80 participants
Study Type
Phase NA interventional
Design
Randomized, single Blind

Detailed Description

Randomized, parallel-group study in patients with chronic visceral pain comorbid major depressive disorder comparing three IV esketamine dose groups (0.125, 0.25, 0.50 mg/kg; 2×/week) plus duloxetine versus an active comparator (pregabalin 75 mg tid plus duloxetine).

Primary aim is to evaluate efficacy and safety (analgesic and antidepressant effects) of adjunctive esketamine; treatment lasts 2 weeks with a 2‑week observation follow-up.

Study Protocol

Preparation

sessions

Dosing

4 sessions

Integration

sessions

Study Arms & Interventions

Pregabalin + Duloxetine

active comparator

Pregabalin capsules administered orally (75 mg three times daily) combined with duloxetine (60–120 mg/day).

Interventions

  • Placebo75 mg
    via Oral• three times daily

    Pregabalin 75 mg tid; plus duloxetine 60–120 mg/day (co‑administered).

Esketamine 0.125 mg/kg

experimental

Intravenous esketamine 0.125 mg/kg plus oral duloxetine (60–120 mg/day); 2×/week for 2 weeks (acute treatment).

Interventions

  • Esketamine0.125 mg/kg
    via IV• twice weekly

    Co‑administered duloxetine 60–120 mg/day.

Esketamine 0.25 mg/kg

experimental

Intravenous esketamine 0.25 mg/kg plus oral duloxetine (60–120 mg/day); 2×/week for 2 weeks (acute treatment).

Interventions

  • Esketamine0.25 mg/kg
    via IV• twice weekly

    Co‑administered duloxetine 60–120 mg/day.

Esketamine 0.50 mg/kg

experimental

Intravenous esketamine 0.50 mg/kg plus oral duloxetine (60–120 mg/day); 2×/week for 2 weeks (acute treatment).

Interventions

  • Esketamine0.5 mg/kg
    via IV• twice weekly

    Co‑administered duloxetine 60–120 mg/day.

Participants

Ages
18 – 55
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 1. Aged 18 to 55
  • 2. Those who can understand and obey the research plan
  • 3. Sign the informed consent form voluntarily
  • 4. Those who meet the DSM-IV-TR depression diagnostic criteria and have first or second episodes of depression
  • 5. Hamilton Depression Scale score ≥ 14 points
  • 6. Those who meet the ICD-11 pain diagnostic criteria, and visual analogue scale score ≥ 7 points. Those who have chronic visceral pain instead of cancer pain.
  • 7. No systemic use of antidepressants and analgesics within 2 weeks after enrollment.

Exclusion Criteria

  • Exclusion Criteria:
  • 1. Female patients who are pregnant, breastfeeding, or preparing to conceive
  • 2. Allergic to duloxetine or pregabalin in the past.
  • 3. A history of serious or unstable physical diseases, such as cardiovascular/liver/kidney/respiratory/endocrine/nervous/blood system disease.
  • 4. A history of epileptic seizures or brain injury, or any neurological disease (including multiple sclerosis, degenerative diseases such as acute lateral sclerosis, Parkinson's disease and movement disorders, etc.).
  • 5. In the last 12 months, the patient has the following medical history or its main diagnosis (DSM-IV-TR) is organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, indeterminate mental disorder, bipolar disorder, psychotic characteristics that are coordinated or uncoordinated with the mood, and history of substance abuse (including alcohol, psychoactive substances, etc.).
  • 6. Patients with a history of adverse reactions to multiple drugs.
  • 7. The patient is taking psychotropic drugs, including benzodiazepines, sleeping pills, anticonvulsants, etc.
  • 8. During the depressive episode, treatment with at least 2 antidepressants in a sufficient course of treatment or at least one SSRI antidepressant treatment is ineffective. A sufficient dose of treatment means treatment with fluoxetine ≥40 mg/day (or sertraline ≥100 mg/day, paroxetine >40 mg/day, fluvoxamine >100 mg/day, citalopram >40 mg/day, escitalopram >20 mg/day, venlafaxine >150 mg/day, duloxetine >80 mg/day).
  • 9. Received electroconvulsive therapy within 6 months before enrollment.
  • 10. Those who are currently at serious risk of suicide, and a score of 3 or higher in item 3 of the 17-HAMD.

Study Details

Locations

China

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