Actively Recruiting

Phase 4
Age: 18Years - 65Years
All Genders
NCT06803485

Effect of Venlafaxine Versus Dosulepin in Pain Predominant Somatic Symptom Disorder

Led by All India Institute of Medical Sciences, Bhubaneswar · Updated on 2025-09-24

84

Participants Needed

1

Research Sites

85 weeks

Total Duration

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AI-Summary

What this Trial Is About

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 options lack definitive efficacy, with pharmacological interventions primarily targeting serotonin pathways. There is limited exploration of therapies addressing mechanisms like cortisol dysregulation and neuroinflammation. Commonly used medications include tricyclic antidepressants (TCAs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and selective serotonin reuptake inhibitors (SSRIs), with prescribing decisions often based on physician discretion and patient tolerance rather than clear evidence favoring one class over another. The proposed study aims to compare the efficacy and safety of Dosulepin (a TCA) and Venlafaxine (an SNRI) in managing SSD patients with predominant pain. By evaluating their impact on symptom severity, quality of life, and biomarkers such as serum cortisol and TNF-alpha levels, this research seeks to enhance understanding of SSD treatment. The findings aim to address gaps in SSD pharmacotherapy and contribute to improved patient care strategies.

CONDITIONS

Official Title

Effect of Venlafaxine Versus Dosulepin in Pain Predominant Somatic Symptom Disorder

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 65 5.
  • All included patients will be treatment-naffve or have not received any treatment in the last 4 weeks.
  • Patients who have given written informed consent.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

All India Institute of Medical Sciences (AIIMS)

Bhubaneswar, Odisha, India, 751019

Actively Recruiting

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Research Team

R

Rituparna Maiti, MD

CONTACT

B

Biswa R Mishra, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Effect of Venlafaxine Versus Dosulepin in Pain Predominant Somatic Symptom Disorder | DecenTrialz