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Effect of Venlafaxine Versus Dosulepin in Pain Predominant Somatic Symptom Disorder

RecruitingPhase 4Ages 18 Years - 65 YearsAllAll India Institute of Medical Sciences, Bhubanes…
NCT06803485 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Somatic symptom disorder (SSD) is marked by persistent physical complaints, often involving pain, alongside excessive thoughts or behaviors related to health, which substantially disrupt daily functioning. The underlying mechanisms of SSD are multifaceted. The serotonin hypothesis links low serotonin levels to the development of somatic symptoms, while the cortisol hypothesis highlights dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis, with chronic stress often associated with hypocortisolism. Furthermore, the neuroinflammatory hypothesis suggests that cytokine-driven inflammation and activation of glial cells may intensify pain and somatic symptoms, exacerbating patient outcomes. Challenges such as limited acceptance of the diagnosis, resistance to treatment among patients and caregivers, and societal stigma further hinder effective management. Currently, treatment option

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients with a primary diagnosis of somatic symptom disorder with pain predominance (DSM-5). * Patients of either sex within the age group of 18-65 years. * Patients with PHQ-15 score of ≥ 5. * All included patients will be treatment-naïve or have not received any treatment in the last 4 weeks. * Patients who have given written informed consent. Exclusion Criteria: * A diagnosed psychological condition that might require other treatment (e.g., psychosis, suicidality) * Patient undergoing current psychotherapy. * Patients with cognitive impairment. * History of allergy to either of the study drugs (dosulepin or venlafaxine). * Patients with comorbidities like any malignancies, hepatic, renal, cardiovascular, neurological or endocrinal, or respiratory dysfunction. * Substance abuse history of psychoactive agents. * Pregnant and lactating mothers.
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What it tests

  • Venlafaxine
  • Dosulepin
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Where

1 site
All India Institute of Medical Sciences (AIIMS)
Bhubaneswar, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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