Recruitment

Recruitment Status
Not yet recruiting

Inclusion Criteria

aged 18 to 55
Those who can understand and obey the research plan
Sign the informed consent form voluntarily
...
aged 18 to 55
Those who can understand and obey the research plan
Sign the informed consent form voluntarily
Hamilton Depression Scale score ≥ 14 points
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.
Those who meet the DSM-IV-TR depression diagnostic criteria and have first or second episodes of depression

Exclusion Criteria

Female patients who are pregnant, breastfeeding, or preparing to conceive
Received electroconvulsive therapy within 6 months before enrollment.
Allergic to duloxetine or pregabalin in the past.
...
Female patients who are pregnant, breastfeeding, or preparing to conceive
Received electroconvulsive therapy within 6 months before enrollment.
Allergic to duloxetine or pregabalin in the past.
Patients with a history of adverse reactions to multiple drugs.
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 mental disorder, delusional mental 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.).
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.);
The patient is taking psychotropic drugs, including benzodiazepines, sleeping pills, anticonvulsants, etc.
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)
A history of serious or unstable physical diseases, such as cardiovascular/liver/kidney/respiratory/ endocrine/nervous/ blood system disease.

Summary

Conditions
  • Chronic Visceral Pain
  • Major Depressive Disorder
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 55 years
Gender
Both males and females

Inclusion Criteria

aged 18 to 55
Those who can understand and obey the research plan
Sign the informed consent form voluntarily
...
aged 18 to 55
Those who can understand and obey the research plan
Sign the informed consent form voluntarily
Hamilton Depression Scale score ≥ 14 points
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.
Those who meet the DSM-IV-TR depression diagnostic criteria and have first or second episodes of depression

Exclusion Criteria

Female patients who are pregnant, breastfeeding, or preparing to conceive
Received electroconvulsive therapy within 6 months before enrollment.
Allergic to duloxetine or pregabalin in the past.
...
Female patients who are pregnant, breastfeeding, or preparing to conceive
Received electroconvulsive therapy within 6 months before enrollment.
Allergic to duloxetine or pregabalin in the past.
Patients with a history of adverse reactions to multiple drugs.
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 mental disorder, delusional mental 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.).
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.);
The patient is taking psychotropic drugs, including benzodiazepines, sleeping pills, anticonvulsants, etc.
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)
A history of serious or unstable physical diseases, such as cardiovascular/liver/kidney/respiratory/ endocrine/nervous/ blood system disease.

Tracking Information

NCT #
NCT04847245
Collaborators
Not Provided
Investigators
Not Provided