Comparing Venlafaxine and Dosulepin for Pain in Somatic Symptom Disorder
Effect of Venlafaxine Versus Dosulepin on Clinical Outcomes, Neuroinflammation and Cortisol Level in Pain Predominant Somatic Symptom Disorder: A Group-sequential Randomized Controlled Trial
This study tests whether two medications, Venlafaxine and Dosulepin, can help adults with somatic symptom disorder who experience pain feel better and improve their daily life.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | All India Institute of Medical Sciences, Bhubaneswar Academic / other |
| Locations | 1 site (Bhubaneswar, Odisha) |
| Trial ID | NCT06803485 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of two medications, Venlafaxine and Dosulepin, in treating patients diagnosed with somatic symptom disorder characterized by pain. The study aims to address the multifaceted nature of the disorder, which includes psychological and physiological components, by evaluating the impact of these treatments on symptoms and overall functioning. Participants will be treatment-naïve or have not received treatment in the last month, ensuring a clear assessment of the medications' effects. The trial will include patients aged 18-65 who meet specific diagnostic criteria and will exclude those with certain psychological or medical conditions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a primary diagnosis of somatic symptom disorder with pain predominance.
Not a fit: Patients with significant psychological conditions requiring different treatments or those currently undergoing psychotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective treatment options for patients suffering from pain-predominant somatic symptom disorder.
How similar studies have performed: While there is limited definitive efficacy in current treatment options for somatic symptom disorder, this approach is novel and aims to explore the effectiveness of these specific medications.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bhubaneswar, Odisha
- All India Institute of Medical Sciences (AIIMS) — Bhubaneswar, Odisha, India (Recruiting)
Study contacts
- Study coordinator: Rituparna Maiti, MD
- Email: pharm_rituparna@aiimsbhubaneswar.edu.in
- Phone: 9438884191
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.