Effect of Venlafaxine Versus Dosulepin in Pain Predominant Somatic Symptom Disorder

NCT ID: NCT06803485

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-11
• Study Completion Date: 2026-11-30

Brief Summary

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

Somatic Symptom Disorder (DSM-V)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Venlafaxine group

Venlafaxine will be started at dose of 37.5mg/day in first week and increased to a stable dose of 75 mg/day from second week and will be continued till 8 weeks.

Group Type: EXPERIMENTAL

Venlafaxine

Intervention Type: DRUG

Venlafaxine will be started at a dose of 37.5 mg/day in first week and increased to a stable dose of 75 mg/day from second week and will be continued till 8 weeks.

Dosulepin group

Dosulepin will be started at dose of 25 mg/day in first week and increased to a stable dose of 50 mg/day from second week and will be continued till 8 weeks.

Group Type: ACTIVE_COMPARATOR

Dosulepin

Intervention Type: DRUG

Dosulepin will be started at a dose of 25 mg/day in first week and increased to a stable dose of 50 mg/day from second week and will be continued till 8 weeeks.

Interventions

Venlafaxine

Venlafaxine will be started at a dose of 37.5 mg/day in first week and increased to a stable dose of 75 mg/day from second week and will be continued till 8 weeks.

Intervention Type: DRUG

Dosulepin

Dosulepin will be started at a dose of 25 mg/day in first week and increased to a stable dose of 50 mg/day from second week and will be continued till 8 weeeks.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

All India Institute of Medical Sciences, Bhubaneswar

OTHER

Sponsor Role: lead

Responsible Party

RITUPARNA MAITI

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

All India Institute of Medical Sciences (AIIMS)

Bhubaneswar, Odisha, India

Site Status: RECRUITING

Countries

India

Central Contacts

Rituparna Maiti, MD

Role: CONTACT

pharm_rituparna@aiimsbhubaneswar.edu.in

9438884191

Biswa R Mishra, MD

Role: CONTACT

psych_biswa@aiimsbhubaneswar.edu.in

9438884220

Facility Contacts

Rituparna Maiti, MD

Role: primary

pharm_rituparna@aiimsbhubaneswar.edu.in

9438884191

Biswa R Mishra, MD

Role: backup

psych_biswa@aiimsbhubaneswar.edu.in

9438884220

References

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Reference Type: BACKGROUND

PMID: 31125145 (View on PubMed)

Park B, Lee S, Jang Y, Park HY. Affective dysfunction mediates the link between neuroimmune markers and the default mode network functional connectivity, and the somatic symptoms in somatic symptom disorder. Brain Behav Immun. 2024 May;118:90-100. doi: 10.1016/j.bbi.2024.02.017. Epub 2024 Feb 13.

Reference Type: BACKGROUND

PMID: 38360374 (View on PubMed)

Rief W, Auer C. Cortisol and somatization. Biol Psychol. 2000 May;53(1):13-23. doi: 10.1016/s0301-0511(00)00042-9.

Reference Type: BACKGROUND

PMID: 10876062 (View on PubMed)

Kurlansik SL, Maffei MS. Somatic Symptom Disorder. Am Fam Physician. 2016 Jan 1;93(1):49-54.

Reference Type: BACKGROUND

PMID: 26760840 (View on PubMed)

D'Souza RS, Hooten WM. Somatic Symptom Disorder. 2023 Mar 13. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK532253/

Reference Type: BACKGROUND

PMID: 30335286 (View on PubMed)

Toussaint A, Kroenke K, Baye F, Lourens S. Comparing the Patient Health Questionnaire - 15 and the Somatic Symptom Scale - 8 as measures of somatic symptom burden. J Psychosom Res. 2017 Oct;101:44-50. doi: 10.1016/j.jpsychores.2017.08.002. Epub 2017 Aug 2.

Reference Type: BACKGROUND

PMID: 28867423 (View on PubMed)

Other Identifiers

PGThesis/2024-25/108

Identifier Type: -

Identifier Source: org_study_id