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Study identifier: NCT06803485 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Effect of Venlafaxine Versus Dosulepin in Pain Predominant Somatic Symptom Disorder

Condition: Somatic Symptom Disorder (DSM-V)  ·  Sponsor: All India Institute of Medical Sciences, Bhubaneswar

PhasePhase 4
Planned participants84
Who can joinAll sexes, 18 Years to 65 Years
Healthy volunteersNo

About this study

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…

This description comes directly from the study's public registry record.

Talk to the study team

Rituparna Maiti, MD  ·  9438884191  ·  pharm_rituparna@aiimsbhubaneswar.edu.in

Biswa R Mishra, MD  ·  9438884220  ·  psych_biswa@aiimsbhubaneswar.edu.in

Always discuss trial participation with your own doctor first.

Locations (1)

All India Institute of Medical Sciences (AIIMS)Bhubaneswar, Odisha, IndiaRecruiting

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Source record: clinicaltrials.gov/study/NCT06803485