Effect of Venlafaxine Versus Dosulepin in Pain Predominant Somatic Symptom Disorder

Phase 4

Recruiting

• Conditions: Somatic Symptom Disorder (DSM-V)
• Interventions: Drug: Venlafaxine; Drug: Dosulepin

• Registration Number: NCT06803485
• Lead Sponsor: All India Institute of Medical Sciences, Bhubaneswar

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-27
• Study First Submitted QC: 2025-01-27
• Study First Posted: 2025-01-31
• Status Verified: 2025-03
• Study Start: 2025-03-11
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-13
• Primary Completion: 2026-08
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Venlafaxine group	Venlafaxine	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.
Dosulepin group	Dosulepin	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.

Primary Outcome Measures

Name	Time	Method
Change in symptoms of Somatic Symptom Disorder using PHQ-15 (Patient health questionnaire) score	8 weeks	The PHQ-15 is a freely accessible self-administered somatic symptoms scale that is based on the full Patient Health Questionnaire. Screening for 15 somatic symptoms.Each symptom is scored as 0, 1, or 2, with the total score ranging from 0 to 30. The scores of \<5, 5-9, 10-14, and 15-30 indicate minimal, low, moderate, and high symptom levels, respectively.

Secondary Outcome Measures

Name	Time	Method
Change in serum cortisol	8 weeks	Change in serum levels of cortisol at baseline after 8 weeks from baseline will be evaluated.The sample will be collected at 8 am.
Treatment response rate	8 weeks	Treatment response rate (defined as a reduction of ≥ 50% of the PHQ-15 score from baseline) will be evaluated.
Change in serum Tumor necrosis factor (TNF) alpha levels	8 weeks	Change in serum levels of TNF-α after 8 weeks from baseline will be evaluated.
Change in quality of life	8 weeks	Quality of life will be evaluated using WHO-QOL BREF scores after 8 weeks from baseline. A condensed version of the WHOQOL-100 questionnaire, the WHOQOL-BREF has 26 items. There are four domains, namely, Physical (domain 1), Psychological (domain 2), Social (domain 3), and Environmental (domain 4) in WHOQOL-BREF. Each question will be evaluated on a scale of 1-5. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life).
Incidence of treatment-emergent adverse events	8 weeks	The Antidepressant Side-Effect Checklist (ASEC) will be used to evaluate the incidence of adverse events. 21 symptom-specific questions are evaluated on a 0-3 scale with "0" denoting absence, "1" denoting mild, "2" denoting moderate, "3" denoting severe, the final score lies in the range of 0-63. Additionally, the scale determines whether a symptom is associated with antidepressants.

Trial Locations

Locations (2)

All India Institute of Medical Sciences (AIIMS); 🇮🇳 Bhubaneswar, Odisha, India

All India Institute of Medical Sciences (AIIMS); 🇮🇳 Bhubaneswar, Odisha, India