Comparing Venlafaxine and Dosulepin for Pain in Somatic Symptom Disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.