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Head-to-Head: which antidepressant eases unexplained pain better?

NCT ID NCT06803485

Symptom relief Sponsor: All India Institute of Medical Sciences, Bhubaneswar Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study compares two antidepressants, venlafaxine and dosulepin, in 84 adults with somatic symptom disorder where pain is the main complaint. Participants take one of the drugs for 8 weeks. Researchers will measure changes in pain and other symptoms, as well as levels of stress hormone cortisol and inflammation markers. The goal is to find which drug works better and why.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Venlafaxine and dosulepin
What this could lead to
If this trial succeeds, it could help doctors choose between two antidepressants for managing pain and other symptoms in somatic symptom disorder.
What could go wrong
This is a small, early-phase trial with only 84 participants. The results may not apply to everyone, and both drugs have side effects like nausea, dizziness, and drowsiness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 84 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

somatization disorder somatoform disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Somatic symptom disorder (DSM-V)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • All India Institute of Medical Sciences (AIIMS)

    RECRUITING

    Bhubaneswar, Odisha, 751019, India