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Somatic Symptom Disorder (DSM-V)Phase 4NCT06803485

Effect of Venlafaxine Versus Dosulepin in Pain Predominant Somatic Symptom Disorder

A Phase 4 study testing Venlafaxine and Dosulepin in people with Somatic Symptom Disorder (DSM-V), run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Somatic Symptom Disorder (DSM-V)
What is being tested?
Venlafaxine and Dosulepin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteIndia
Study dates
11 Mar 2025to Nov 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rituparna Maiti, MD contact

9438884191

pharm_rituparna@aiimsbhubaneswar.edu.in

Biswa R Mishra, MD contact

9438884220

psych_biswa@aiimsbhubaneswar.edu.in

India1 site, 1 recruiting

  • All India Institute of Medical Sciences (AIIMS)

    Bhubaneswar, Odisha, 751019

    Rituparna Maiti, MD, 9438884191, pharm_rituparna@aiimsbhubaneswar.edu.in

    Biswa R Mishra, MD, 9438884220, psych_biswa@aiimsbhubaneswar.edu.in

    Recruiting

Other trials in India

About this study

Official title: Effect of Venlafaxine Versus Dosulepin on Clinical Outcomes, Neuroinflammation and Cortisol Level in Pain Predominant Somatic Symptom Disorder: A Group-sequential Randomized Controlled Trial

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.

Being tested
Venlafaxine, Dosulepin
Keywords
Somatic symptom disorder, Dosulepin, Venlafaxine, Somatic syndrome disorder with pain predominance, Cortisol, TNF alpha

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VenlafaxineDrug

    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.

  • DosulepinDrug

    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.

Study groups in NCT06803485
Study groupRoleWhat they receive
Venlafaxine groupExperimentalVenlafaxine 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.
Receives: Drug: Venlafaxine
Dosulepin groupActive comparatorDosulepin 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.
Receives: Drug: Dosulepin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in symptoms of Somatic Symptom Disorder using PHQ-15 (Patient health questionnaire) score

    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.

    Measured: 8 weeks

Secondary outcomes (5)

  1. Treatment response rate

    Treatment response rate (defined as a reduction of ≥ 50% of the PHQ-15 score from baseline) will be evaluated.

    Measured: 8 weeks

  2. Change in serum cortisol

    Change in serum levels of cortisol at baseline after 8 weeks from baseline will be evaluated.The sample will be collected at 8 am.

    Measured: 8 weeks

  3. Change in serum Tumor necrosis factor (TNF) alpha levels

    Change in serum levels of TNF-α after 8 weeks from baseline will be evaluated.

    Measured: 8 weeks

  4. Change in quality of life

    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).

    Measured: 8 weeks

  5. Incidence of treatment-emergent adverse events

    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.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2025
  2. Study start11 Mar 2025
  3. Primary completionAug 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Group Sequential Study Model
Masking
None (open label)
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06803485
Sponsor's protocol ID
PGThesis/2024-25/108
Status last verified
Sep 2025
First submitted
27 Jan 2025
Last updated
24 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) underlying the results of this study will be shared with qualified researchers upon reasonable request. Data will be available after publication and subject to review of a data access proposal and data use agreement.

Publications

  • Miyauchi T, Tokura T, Kimura H, Ito M, Umemura E, Sato Boku A, Nagashima W, Tonoike T, Yamamoto Y, Saito K, Kurita K, Ozaki N. Effect of antidepressant treatment on plasma levels of neuroinflammation-associated molecules in patients with somatic symptom disorder with predominant pain around the orofacial region. Hum Psychopharmacol. 2019 Jul;34(4):e2698. doi: 10.1002/hup.2698. Epub 2019 May 24.

    PubMed 31125145

  • 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.

    PubMed 38360374

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

    PubMed 10876062

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

    PubMed 26760840

  • D'Souza RS, Hooten WM. Somatic Symptom Disorder. 2023 Mar 13. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK532253/

    PubMed 30335286

  • 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.

    PubMed 28867423

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Venlafaxine and Dosulepin in people with Somatic Symptom Disorder (DSM-V), run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rituparna Maiti, MD (9438884191, pharm_rituparna@aiimsbhubaneswar.edu.in), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in symptoms of Somatic Symptom Disorder using PHQ-15 (Patient health questionnaire) score (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06803485, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.

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