Treatment Resistant DepressionPhase 4APQ-TRDNCT04936126
Comparison of Antidepressant Augmentation With Amantadine vs Pramipexole vs Quetiapine in Treatment Resistant Depression
A Phase 4 study testing Quetiapine, Amantadine and Pramipexole in people with Treatment Resistant Depression, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
Trial summary
The present study has been designed to compare the efficacy and safety of augmentation of SSRIs with Amantadine vs Pramipexole vs the recommended Quetiapine augmentation in Treatment-Resistant Depression (TRD) and correlate the changes in depression scores with changes in the serum levels of Brain-derived neurotrophic… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Treatment Resistant Depression
- What is being tested?
- Quetiapine, Amantadine and Pramipexole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIndia
- Study dates
- 7 Aug 2021to 7 Sep 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with unipolar depression clinically diagnosed as TRD, who are currently on Sertraline treatment (dose range = 100-200 mg/day)
- Patients aged 18-60 years of either sex
Who cannot join
- Patients with Bipolar affective disorder
- Patient with TRD on antidepressants other than Sertraline
- History of psychoactive substance abuse or dependence
- Co-morbid psychiatric, major medical, or neurological disorders
- History of organicity or significant head injury
- Pregnant and lactating women
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
All India Institute of Medical Sciences
Bhubaneswar, Odisha, 751019
Biswa R Mishra, MD, DPM, 9438884220, brm1678@gmail.com
Rituparna Maiti, MD, 9438884191, rituparnamaiti@gmail.com
About this study
Official title: Comparative Efficacy of Antidepressant Augmentation With Amantadine vs Pramipexole vs Quetiapine in Treatment-resistant Unipolar Depression: A Randomized Controlled Trial.
The present study has been designed to compare the efficacy and safety of augmentation of SSRIs with Amantadine vs Pramipexole vs the recommended Quetiapine augmentation in Treatment-Resistant Depression (TRD) and correlate the changes in depression scores with changes in the serum levels of Brain-derived neurotrophic factor (BDNF) and Nerve growth factor (NGF).
The proposed study will be a prospective, randomized, single-blind, controlled clinical trial in patients with TRD and will be conducted over a period of 2 years. The study cohort will comprise 150 patients with unipolar depression clinically diagnosed as TRD, who are currently on Sertraline treatment (dose range = 100-200 mg/day). At baseline, Hamilton Depression Scale (HAM-D 21 item) will be administered to determine the severity of depressive symptoms, Clinical Global Inventory (CGI) will be administered to determine the baseline severity of the illness. Serum BDNF, and NGF will be estimated by ELISA using commercially available Human ELISA kit. The sample will be divided into 3 equal treatment groups by block randomization technique, each group comprising of 50 patients.
Read more
Group 1 will receive Amantadine 200 mg/day (in two divided doses) augmentation to the ongoing Sertraline treatment. Group 2 will receive Pramipexole 0.375 mg/day (in three divided doses) augmentation to the ongoing Sertraline treatment. Group 3 will serve as the control arm and receive the recommended Quetiapine XR 100 mg/day augmentation to the ongoing Sertraline treatment.
The study cohort will be reassessed for the changes in HAM-D scores, CGI severity scores, Improvement score and Efficacy index, at 4 and 8 weeks follow up. The changes in Serum BDNF, and NGF will be estimated at the end of 8 weeks, to correlate with the change in severity of depressive symptoms. All the participants will be evaluated for any untoward side effects in a prescribed format for the Pharmacovigilance program of India (PVPI). The patient in either of the treatment arms, who are not responding to treatment or relapsing with aggravation of depressive symptoms will be switched on to Venlafaxine treatment or Electro-convulsive therapy (ECT) as decided by the treating team.
Read the detailed description
STUDY OBJECTIVES:
Primary Objective
- To compare the change in the severity of symptoms of depression in terms of change in HAM-D scores between the treatment groups over 8 weeks.
Secondary Objective
- To compare the change in CGI scores between the treatment groups over 8 weeks.
- To evaluate the change in serum BDNF, serum NGF levels between the treatment groups over 8 weeks.
- To detect adverse drug reactions (if any) (prescribed format for Pharmacovigilance program of India PVPI)
Study design:
This study will be a hospital-based, prospective, randomized, single-blind, controlled clinical trial in patients with unipolar depression clinically diagnosed as TRD, which will be conducted over a period of 3 years.
Study population and eligibility:
The study cohort will comprise of 150 patients with the diagnosis of unipolar treatment-resistant depression (TRD), attending the in-patient or out-patient department of Psychiatry, All India Institute of Medical Sciences, Bhubaneswar. The patient should have received adequate trials of at least two antidepressants (one of which preferably should be an SSRI) at adequate dose and duration (> 6 weeks), with poor clinical response while on regular compliance. The patients fulfilling the criteria who are currently on Sertraline treatment (dose range = 100-200 mg/day), giving written informed consent will be recruited for the present study. The detailed history, relevant socio-demographic, and clinical data will be collected in a structured case record form (CRF).
Study Procedure and Data collection:
Baseline assessment:
At baseline, Hamilton Depression Scale (HAM-D 21 item) will be administered to determine the severity of depressive symptoms, Clinical Global Inventory (CGI) will be administered to determine the baseline severity of the illness. Serum BDNF, and NGF will be estimated by ELISA using commercially available Human ELISA kit.
Randomization:
The study cohort of 150 participants will be randomized into three treatment groups by block randomization technique (computer-generated) with 25 blocks, each block with 6 participants. The sample will be divided into 3 equal treatment groups, each group comprising of 50 patients.
Treatment Allocation:
Group 1 will receive Amantadine 200 mg/day (in two divided doses) augmentation to the ongoing Sertraline treatment. Group 2 will receive Pramipexole 0.375 mg/day (in three divided doses) augmentation to the ongoing Sertraline treatment. Group 3 will serve as the control arm and receive the recommended Quetiapine XR 100 mg/day augmentation to the ongoing Sertraline treatment.
Follow up assessment:
The study cohort will be reassessed for the changes in HAM-D scores, CGI severity scores, Improvement score, and Efficacy index, at 4 and 8 weeks follow up. The changes in Serum BDNF and NGF will be estimated at the end of 8 weeks, to correlate with the change in the severity of depressive symptoms.
Rescue Medication:
The patient in either of the treatment arms, who are not responding to treatment or relapsing with aggravation of depressive symptoms will be switched on to Venlafaxine treatment or ECT as decided by the treating team.
Safety evaluation:
All the participants will be evaluated for any untoward side effects like insomnia, restlessness, and agitation, etc. which will be documented and informed to the institutional ethics committee.
- Conditions
- Treatment Resistant Depression
- Being tested
- Quetiapine, Amantadine, Pramipexole
- Keywords
- Treatment Resistant Depression, Augmentation, Amantadine, Pramipexole, BDNF, NGF
- Medical subject headings
- Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuetiapineDrug
Quetiapine XR 100 mg/day augmentation to the ongoing Sertraline treatment for the study period
AmantadineDrug
Amantadine 200 mg/day (in two divided doses) augmentation to the ongoing Sertraline treatment for the study period
PramipexoleDrug
Pramipexole 0.375 mg/day (in three divided doses) augmentation to the ongoing Sertraline treatment for the study period
| Study group | Role | What they receive |
|---|---|---|
| Quetiapine group | Active comparator | Quetiapine XR 100 mg/day augmentation to the ongoing Sertraline treatment. Receives: Drug: Quetiapine |
| Amantadine group | Experimental | Amantadine 200 mg/day (in two divided doses) augmentation to the ongoing Sertraline treatment Receives: Drug: Amantadine |
| Pramipexole group | Experimental | Pramipexole 0.375 mg/day (in three divided doses) augmentation to the ongoing Sertraline treatment Receives: Drug: Pramipexole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Scale scores
Change in Hamilton Depression Scale scores 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression Higher scores indicating higher severity of depression
Measured: 8 weeks
Secondary outcomes (4)
Clinical Global Impression scores
Change in Clinical Global Impression scores CGI-S severity scores range from 1-7, with higher scores indicating greater severity of illness CGI-I Improvement score range from 1-7, with lower scores indicating improvement and higher scores indicating worsening
Measured: 8 weeks
Serum Brain Derived Neurotrophic Factor
Change in Serum Brain Derived Neurotrophic Factor levels
Measured: 8 weeks
Serum Nerve Growth Factor
Change in Serum Nerve Growth Factor
Measured: 8 week
Rescue Medications
Number of patients in the Rescue medication group
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start7 Aug 2021
- Primary completion7 Jul 2024 (estimated)
- Study completion7 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Treatment Resistant DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prospective, parallel-arm, randomized, single-blind, controlled clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Sponsor type
- University, hospital or other
- Collaborators
- Indian Council of Medical Research
- Responsible party
- Principal investigator, BISWA RANJAN MISHRA, All India Institute of Medical Sciences, Bhubaneswar
- Investigators
- Debadatta Mohapatra, MD, Study chair, All India Institute of Medical Sciences, Bhubaneswar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936126
- Sponsor's protocol ID
- T/EMF/Psych/19/49
- Acronym
- APQ-TRD
- Status last verified
- Aug 2023
- First submitted
- 14 Jun 2021
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1545-1602. doi: 10.1016/S0140-6736(16)31678-6.
PubMed 27733282Kennedy SH, Giacobbe P. Treatment resistant depression--advances in somatic therapies. Ann Clin Psychiatry. 2007 Oct-Dec;19(4):279-87. doi: 10.1080/10401230701675222.
PubMed 18058285Fava M, Davidson KG. Definition and epidemiology of treatment-resistant depression. Psychiatr Clin North Am. 1996 Jun;19(2):179-200. doi: 10.1016/s0193-953x(05)70283-5.
PubMed 8827185Souery D, Amsterdam J, de Montigny C, Lecrubier Y, Montgomery S, Lipp O, Racagni G, Zohar J, Mendlewicz J. Treatment resistant depression: methodological overview and operational criteria. Eur Neuropsychopharmacol. 1999 Jan;9(1-2):83-91. doi: 10.1016/s0924-977x(98)00004-2.
PubMed 10082232Dold M, Kasper S. Evidence-based pharmacotherapy of treatment-resistant unipolar depression. Int J Psychiatry Clin Pract. 2017 Mar;21(1):13-23. doi: 10.1080/13651501.2016.1248852. Epub 2016 Nov 16.
PubMed 27848269Fleurence R, Williamson R, Jing Y, Kim E, Tran QV, Pikalov AS, Thase ME. A systematic review of augmentation strategies for patients with major depressive disorder. Psychopharmacol Bull. 2009;42(3):57-90.
PubMed 19752841Mishra BR, Mohapatra D, Biswas T, Mishra A, Panigrahi S, Maiti R. Comparative efficacy of antidepressant augmentation with amantadine vs pramipexole in treatment-resistant unipolar depression: A randomised controlled trial. J Affect Disord. 2025 Dec 1;390:119891. doi: 10.1016/j.jad.2025.119891. Epub 2025 Jul 13.
PubMed 40659070
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Antidepressant Augmentation With Amantadine vs Pramipexole vs Quetiapine in Treatment-resistant Unipolar Depression: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04936126
- Acronym / sponsor ID
- APQ-TRD / T/EMF/Psych/19/49
- Conditions
- Treatment Resistant Depression
- Keywords
- Treatment Resistant Depression, Augmentation, Amantadine, Pramipexole, BDNF, NGF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- All India Institute of Medical Sciences, BhubaneswarUniversity, hospital or other
- Collaborators
- Indian Council of Medical Research
- Study start
- 7 Aug 2021 (actual)
- Primary completion
- 7 Jul 2024 (estimated)
- Study completion
- 7 Sep 2024 (estimated)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study has been designed to compare the efficacy and safety of augmentation of SSRIs with Amantadine vs Pramipexole vs the recommended Quetiapine augmentation in Treatment-Resistant Depression (TRD) and correlate the changes in depression scores with changes in the serum levels of Brain-derived neurotrophic factor (BDNF) and Nerve growth factor (NGF).
The proposed study will be a prospective, randomized, single-blind, controlled clinical trial in patients with TRD and will be conducted over a period of 2 years. The study cohort will comprise 150 patients with unipolar depression clinically diagnosed as TRD, who are currently on Sertraline treatment (dose range = 100-200 mg/day). At baseline, Hamilton Depression Scale (HAM-D 21 item) will be administered to determine the severity of depressive symptoms, Clinical Global Inventory (CGI) will be administered to determine the baseline severity of the illness. Serum BDNF, and NGF will be estimated by ELISA using commercially available Human ELISA kit. The sample will be divided into 3 equal treatment groups by block randomization technique, each group comprising of 50 patients.
Group 1 will receive Amantadine 200 mg/day (in two divided doses) augmentation to the ongoing Sertraline treatment. Group 2 will receive Pramipexole 0.375 mg/day (in three divided doses) augmentation to the ongoing Sertraline treatment. Group 3 will serve as the control arm and receive the recommended Quetiapine XR 100 mg/day augmentation to the ongoing Sertraline treatment.
The study cohort will be reassessed for the changes in HAM-D scores, CGI severity scores, Improvement score and Efficacy index, at 4 and 8 weeks follow up. The changes in Serum BDNF, and NGF will be estimated at the end of 8 weeks, to correlate with the change in severity of depressive symptoms. All the participants will be evaluated for any untoward side effects in a prescribed format for the Pharmacovigilance program of India (PVPI). The patient in either of the treatment arms, who are not responding to treatment or relapsing with aggravation of depressive symptoms will be switched on to Venlafaxine treatment or Electro-convulsive therapy (ECT) as decided by the treating team.
Detailed description
STUDY OBJECTIVES:
Primary Objective
- To compare the change in the severity of symptoms of depression in terms of change in HAM-D scores between the treatment groups over 8 weeks.
Secondary Objective
- To compare the change in CGI scores between the treatment groups over 8 weeks.
- To evaluate the change in serum BDNF, serum NGF levels between the treatment groups over 8 weeks.
- To detect adverse drug reactions (if any) (prescribed format for Pharmacovigilance program of India PVPI)
Study design:
This study will be a hospital-based, prospective, randomized, single-blind, controlled clinical trial in patients with unipolar depression clinically diagnosed as TRD, which will be conducted over a period of 3 years.
Study population and eligibility:
The study cohort will comprise of 150 patients with the diagnosis of unipolar treatment-resistant depression (TRD), attending the in-patient or out-patient department of Psychiatry, All India Institute of Medical Sciences, Bhubaneswar. The patient should have received adequate trials of at least two antidepressants (one of which preferably should be an SSRI) at adequate dose and duration (> 6 weeks), with poor clinical response while on regular compliance. The patients fulfilling the criteria who are currently on Sertraline treatment (dose range = 100-200 mg/day), giving written informed consent will be recruited for the present study. The detailed history, relevant socio-demographic, and clinical data will be collected in a structured case record form (CRF).
Study Procedure and Data collection:
Baseline assessment:
At baseline, Hamilton Depression Scale (HAM-D 21 item) will be administered to determine the severity of depressive symptoms, Clinical Global Inventory (CGI) will be administered to determine the baseline severity of the illness. Serum BDNF, and NGF will be estimated by ELISA using commercially available Human ELISA kit.
Randomization:
The study cohort of 150 participants will be randomized into three treatment groups by block randomization technique (computer-generated) with 25 blocks, each block with 6 participants. The sample will be divided into 3 equal treatment groups, each group comprising of 50 patients.
Treatment Allocation:
Group 1 will receive Amantadine 200 mg/day (in two divided doses) augmentation to the ongoing Sertraline treatment. Group 2 will receive Pramipexole 0.375 mg/day (in three divided doses) augmentation to the ongoing Sertraline treatment. Group 3 will serve as the control arm and receive the recommended Quetiapine XR 100 mg/day augmentation to the ongoing Sertraline treatment.
Follow up assessment:
The study cohort will be reassessed for the changes in HAM-D scores, CGI severity scores, Improvement score, and Efficacy index, at 4 and 8 weeks follow up. The changes in Serum BDNF and NGF will be estimated at the end of 8 weeks, to correlate with the change in the severity of depressive symptoms.
Rescue Medication:
The patient in either of the treatment arms, who are not responding to treatment or relapsing with aggravation of depressive symptoms will be switched on to Venlafaxine treatment or ECT as decided by the treating team.
Safety evaluation:
All the participants will be evaluated for any untoward side effects like insomnia, restlessness, and agitation, etc. which will be documented and informed to the institutional ethics committee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective, parallel-arm, randomized, single-blind, controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Quetiapine group | Active comparator | Drug: QuetiapineQuetiapine XR 100 mg/day augmentation to the ongoing Sertraline treatment. |
| Amantadine group | Experimental | Drug: AmantadineAmantadine 200 mg/day (in two divided doses) augmentation to the ongoing Sertraline treatment |
| Pramipexole group | Experimental | Drug: PramipexolePramipexole 0.375 mg/day (in three divided doses) augmentation to the ongoing Sertraline treatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with unipolar depression clinically diagnosed as TRD, who are currently on Sertraline treatment (dose range = 100-200 mg/day)
- Patients aged 18-60 years of either sex
Key exclusion criteria (6 listed)
- Patients with Bipolar affective disorder
- Patient with TRD on antidepressants other than Sertraline
- History of psychoactive substance abuse or dependence
- Co-morbid psychiatric, major medical, or neurological disorders
- History of organicity or significant head injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuetiapineQuetiapine XR 100 mg/day augmentation to the ongoing Sertraline treatment for the study period | Drug | Quetiapine group |
| AmantadineAmantadine 200 mg/day (in two divided doses) augmentation to the ongoing Sertraline treatment for the study period | Drug | Amantadine group |
| PramipexolePramipexole 0.375 mg/day (in three divided doses) augmentation to the ongoing Sertraline treatment for the study period | Drug | Pramipexole group |
Primary outcome
Hamilton Depression Scale scores
Time frame: 8 weeks
Change in Hamilton Depression Scale scores 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression Higher scores indicating higher severity of depression
4 secondary outcomes
Clinical Global Impression scores
Time frame: 8 weeks
Serum Brain Derived Neurotrophic Factor
Time frame: 8 weeks
Serum Nerve Growth Factor
Time frame: 8 week
Rescue Medications
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Results publication: PubMed 27733282GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1545-1602. doi: 10.1016/S0140-6736(16)31678-6.
- Results publication: PubMed 18058285Kennedy SH, Giacobbe P. Treatment resistant depression--advances in somatic therapies. Ann Clin Psychiatry. 2007 Oct-Dec;19(4):279-87. doi: 10.1080/10401230701675222.
- Results publication: PubMed 8827185Fava M, Davidson KG. Definition and epidemiology of treatment-resistant depression. Psychiatr Clin North Am. 1996 Jun;19(2):179-200. doi: 10.1016/s0193-953x(05)70283-5.
- Results publication: PubMed 10082232Souery D, Amsterdam J, de Montigny C, Lecrubier Y, Montgomery S, Lipp O, Racagni G, Zohar J, Mendlewicz J. Treatment resistant depression: methodological overview and operational criteria. Eur Neuropsychopharmacol. 1999 Jan;9(1-2):83-91. doi: 10.1016/s0924-977x(98)00004-2.
- Results publication: PubMed 27848269Dold M, Kasper S. Evidence-based pharmacotherapy of treatment-resistant unipolar depression. Int J Psychiatry Clin Pract. 2017 Mar;21(1):13-23. doi: 10.1080/13651501.2016.1248852. Epub 2016 Nov 16.
- Results publication: PubMed 19752841Fleurence R, Williamson R, Jing Y, Kim E, Tran QV, Pikalov AS, Thase ME. A systematic review of augmentation strategies for patients with major depressive disorder. Psychopharmacol Bull. 2009;42(3):57-90.
- Derived from this study: PubMed 40659070Mishra BR, Mohapatra D, Biswas T, Mishra A, Panigrahi S, Maiti R. Comparative efficacy of antidepressant augmentation with amantadine vs pramipexole in treatment-resistant unipolar depression: A randomised controlled trial. J Affect Disord. 2025 Dec 1;390:119891. doi: 10.1016/j.jad.2025.119891. Epub 2025 Jul 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debadatta Mohapatra, MD study chair
All India Institute of Medical Sciences, Bhubaneswar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Quetiapine, Amantadine and Pramipexole in people with Treatment Resistant Depression, 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 22 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Biswa R Mishra, MD, DPM (9438884220, brm1678@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Scale scores (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 NCT04936126, which also lists 7 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 22 Aug 2023.