Depressive DisorderPhase 4NCT02263872
Minocycline as an Adjunct for the Treatment of Depressive Symptoms: Pilot Randomized Controlled Trial
A Phase 4 study testing Minocycline in people with Depressive Disorder and Mood Disorders, run by Pakistan Institute of Living and Learning at 3 sites in Pakistan.
Trial summary
In this double blind randomised controlled pilot trial the investigators aim to determine the efficacy of minocycline as an adjunct to treatment as usual in patients with major depressive disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Disorder, Mood Disorders, Depressive Disorder, Treatment Resistant
- What is being tested?
- Minocycline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 3 sitesPakistan
- Study dates
- Oct 2014to Aug 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged 18-65 years
- Diagnostic and Statistical Manual-IV (DSM-IV) diagnosis of major depressive disorder
- competent and willing to give informed consent
- taking the current antidepressant medication for a minimum of 4 weeks prior to baseline
- the current episode of depression has failed to remit with at least two courses of antidepressant treatment (one of which is the current course)
- able to take oral medication
- if female, willing to use adequate contraceptive precautions and to have monthly pregnancy tests.
Who cannot join
- relevant medical illness (renal, hepatic, cardiac, serious dermatological disorders such as exfoliative dermatitis, systemic lupus erythematosis)
- prior history of intolerance to any of the tetracyclines
- concomitant penicillin therapy
- concomitant anticoagulant therapy
- presence of a seizure disorder
- currently taking valproic acid
Show all 10Show fewer
- any change of psychotropic medications within the previous 4 weeks
- diagnosis of substance abuse (except nicotine or caffeine) or dependence within the last 3 months according to DSM-IV criteria
- pregnant or breast-feeding
- presence of primary psychotic disorder.
Trial locations and contacts
3 sites in 1 country.
Pakistan3 sites
Abasi Shaheed Hospital
Karachi, Sindh, 72000
Civil hospital Karachi
Karachi, Sindh, 72000
Karwan-e-Hayat
Karachi, Sindh
About this study
In this double blind randomised controlled pilot trial the investigators aim to determine the efficacy of minocycline as an adjunct to treatment as usual in patients with major depressive disorder. The investigators hypothesize that the multiple neuroprotective effects of minocycline will lead to an improvement in depressive symptoms in participants that were given minocycline plus treatment as usual
Read the detailed description
Major depressive disorder is associated with significant morbidity and mortality. According to the WHO, depression is the leading cause of disability worldwide in terms of years lost due to disability [1]. Although depressive symptoms are amenable to antidepressant treatment, a high proportion of patients does not respond or remit. For example in the Sequenced Treatment Alternatives for the Relief of Depression (STAR*D) study the response and remission rates with stage 1 treatment (citalopram) were 49% and 37% respectively and these rates decreased to 16% and 13% respectively over the subsequent next three treatment steps [2]. Clearly there is a need for new treatment approaches.
Recently there has been significant preclinical and clinical study linking inflammatory processes to a range of psychiatric illness including depression, schizophrenia, bipolar disorder and Alzheimer's disease. The evidence that depression is an inflammatory related disorder comes from multiple sources. Depression is associated with raised inflammatory markers even in the absence of a medical illness [3]. More specifically depression has been associated with higher levels of positive acute phase proteins (APPs) and low levels of negative APPs [4] as well as increased levels of complement factors C3c and C4 and immunoglobulin M (IgM) and IgG [5]. Inflammatory medical illness, both CNS and peripheral, are associated with greater rates of depression. In patients with Crohns disease and comorbid depression bouts of physical disease activity tend to co-occur with depressive episodes [6]. Finally, patients treated with cytokines for various illnesses have an increased risk of developing depressive illness [7]. For example, treatment with cytokine IFN-α leads to the development of depressive symptoms in up to 45% of patients [8].
With this in mind it would seem logical to hypothesise that the addition of an anti-inflammatory medication may be a treatment option in depressive illness. Muller et al [9] were successful in showing this when they used Celcoxib in addition to Reboxetine for the treatment of major depressive disorder in a double-blind, randomised, placebo-controlled pilot study. Other studies have shown that TNF (tumour necrosis factor) blocking agents such as Infliximab and Ethanercept improve mood independent of improvement in inflammatory condition [10]. However some studies have found that anti-inflammatories may in fact have an antagonistic effect on the antidepressant actions of SSRIs [11]. Further work is needed in this area to clarify the role of inflammatory processes and anti-inflammatories in the treatment of depression.
Alongside the current interest in the use of anti-inflammatories as novel treatments in psychiatric illness, the antibiotic minocycline has also been proposed for the treatment of depressive symptoms as well as negative symptoms in schizophrenia [12, 13]. Preliminary data from an open label study of patients with psychotic unipolar depression also suggested that minocycline augmentation of antidepressant treatment was effective and well tolerated [14]. Minocycline is a pleiotropic agent that exerts effects on multiple interacting symptoms (e.g. anti-inflammatory, anti-oxidant, anti-apoptotic, anti-gutamatergic, monaminergic) implicated in the pathophysiology of mood disorders. Despite such neuroprotective properties, there have been no clinical trials to date investigating the antidepressant effects of minocycline in individuals. The investigators have previously shown that the addition of minocycline to treatment as usual early in the course of schizophrenia leads to a predominant improvement in negative symptoms.
In this double blind randomised controlled pilot trial the investigators aim to determine the efficacy of minocycline as an adjunct to treatment as usual in patients with major depressive disorder. The investigators hypothesise that the multiple neuroprotective effects of minocycline will lead to an improvement in depressive symptoms in participants that were given minocycline plus treatment as usual.
Aim To investigate whether the addition of minocycline to treatment as usual (TAU) for 3 months in patients with major depressive disorder will lead to an improvement in depressive symptoms compared with TAU.
Methods
Double blind randomised, placebo-controlled pilot trial.
The study will be conducted in Karachi, Pakistan. Patients will be recruited from psychiatric units in Karachi. All patients will give written informed consent after reading information in Urdu, witnessed almost always by a relative.
- Conditions
- Depressive Disorder, Mood Disorders, Depressive Disorder, Treatment Resistant, Antidepressive Agents
- Being tested
- Minocycline
- Medical subject headings
- Depressive Disorder, Mood Disorders, Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinocyclineDrug
Also called mesodrum
Minocycline 200mg perday
| Study group | Role | What they receive |
|---|---|---|
| Minocycline | Experimental | Minocycline 200mg perday Receives: Drug: Minocycline |
| comparison group with placebo | Placebo comparator | Placebo provide Receives: Drug: Minocycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary clinical outcome measures will be mean change from baseline on the Hamilton Depression Scale scores
Measured: 12 weeks
Secondary outcomes (3)
PHQ-9
Measured: Baseline, Week 2, week 4, week 8, week 12
GAD-7
Measured: Baseline, Week 2, week 4, week 8, week 12
CGI
Measured: Baseline, Week 2, week 4, week 8, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJun 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Living and Learning
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Dr. Muhammad Ishrat, Principal investigator, Institute of Psychiatry, Psychology and Neuroscience, Kings college London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02263872
- Sponsor's protocol ID
- MINDEP001
- Status last verified
- Sep 2016
- First submitted
- 8 Oct 2014
- Last updated
- 5 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
World Health Organization. The Global Burden of Disease. Geneva: WHO Press; 2012.
Rush AJ, Trivedi MH, Wisniewski SR, Nierenberg AA, Stewart JW, Warden D, Niederehe G, Thase ME, Lavori PW, Lebowitz BD, McGrath PJ, Rosenbaum JF, Sackeim HA, Kupfer DJ, Luther J, Fava M. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006 Nov;163(11):1905-17. doi: 10.1176/ajp.2006.163.11.1905.
PubMed 17074942O'Donovan A, Rush G, Hoatam G, Hughes BM, McCrohan A, Kelleher C, O'Farrelly C, Malone KM. Suicidal ideation is associated with elevated inflammation in patients with major depressive disorder. Depress Anxiety. 2013 Apr;30(4):307-14. doi: 10.1002/da.22087. Epub 2013 Mar 15.
PubMed 23504697Dantzer R, O'Connor JC, Freund GG, Johnson RW, Kelley KW. From inflammation to sickness and depression: when the immune system subjugates the brain. Nat Rev Neurosci. 2008 Jan;9(1):46-56. doi: 10.1038/nrn2297.
PubMed 18073775Song C, Dinan T, Leonard BE. Changes in immunoglobulin, complement and acute phase protein levels in the depressed patients and normal controls. J Affect Disord. 1994 Apr;30(4):283-8. doi: 10.1016/0165-0327(94)90135-x.
PubMed 7516941Mardini HE, Kip KE, Wilson JW. Crohn's disease: a two-year prospective study of the association between psychological distress and disease activity. Dig Dis Sci. 2004 Mar;49(3):492-7. doi: 10.1023/b:ddas.0000020509.23162.cc.
PubMed 15139504Van Gool AR, Kruit WH, Engels FK, Stoter G, Bannink M, Eggermont AM. Neuropsychiatric side effects of interferon-alfa therapy. Pharm World Sci. 2003 Feb;25(1):11-20. doi: 10.1023/a:1022449613907.
PubMed 12661471Capuron L, Miller AH. Immune system to brain signaling: neuropsychopharmacological implications. Pharmacol Ther. 2011 May;130(2):226-38. doi: 10.1016/j.pharmthera.2011.01.014. Epub 2011 Feb 17.
PubMed 21334376Muller N, Schwarz MJ, Dehning S, Douhe A, Cerovecki A, Goldstein-Muller B, Spellmann I, Hetzel G, Maino K, Kleindienst N, Moller HJ, Arolt V, Riedel M. The cyclooxygenase-2 inhibitor celecoxib has therapeutic effects in major depression: results of a double-blind, randomized, placebo controlled, add-on pilot study to reboxetine. Mol Psychiatry. 2006 Jul;11(7):680-4. doi: 10.1038/sj.mp.4001805. Epub 2006 Feb 21.
PubMed 16491133Krishnadas R, Cavanagh J. Depression: an inflammatory illness? J Neurol Neurosurg Psychiatry. 2012 May;83(5):495-502. doi: 10.1136/jnnp-2011-301779. Epub 2012 Mar 15.
PubMed 22423117Warner-Schmidt JL, Vanover KE, Chen EY, Marshall JJ, Greengard P. Antidepressant effects of selective serotonin reuptake inhibitors (SSRIs) are attenuated by antiinflammatory drugs in mice and humans. Proc Natl Acad Sci U S A. 2011 May 31;108(22):9262-7. doi: 10.1073/pnas.1104836108. Epub 2011 Apr 25.
PubMed 21518864Soczynska JK, Mansur RB, Brietzke E, Swardfager W, Kennedy SH, Woldeyohannes HO, Powell AM, Manierka MS, McIntyre RS. Novel therapeutic targets in depression: minocycline as a candidate treatment. Behav Brain Res. 2012 Dec 1;235(2):302-17. doi: 10.1016/j.bbr.2012.07.026. Epub 2012 Aug 10.
PubMed 22963995Chaudhry IB, Hallak J, Husain N, Minhas F, Stirling J, Richardson P, Dursun S, Dunn G, Deakin B. Minocycline benefits negative symptoms in early schizophrenia: a randomised double-blind placebo-controlled clinical trial in patients on standard treatment. J Psychopharmacol. 2012 Sep;26(9):1185-93. doi: 10.1177/0269881112444941. Epub 2012 Apr 23.
PubMed 22526685Miyaoka T, Furuya M, Yasuda H, Hayashida M, Nishida A, Inagaki T, Horiguchi J. Yi-gan san as adjunctive therapy for treatment-resistant schizophrenia: an open-label study. Clin Neuropharmacol. 2009 Jan-Feb;32(1):6-9. doi: 10.1097/WNF.0b013e31817e08c3.
PubMed 19471183Zazula R, Husain MI, Mohebbi M, Walker AJ, Chaudhry IB, Khoso AB, Ashton MM, Agustini B, Husain N, Deakin J, Young AH, Berk M, Kanchanatawan B, Ng CH, Maes M, Berk L, Singh AB, Malhi GS, Dean OM. Minocycline as adjunctive treatment for major depressive disorder: Pooled data from two randomized controlled trials. Aust N Z J Psychiatry. 2021 Aug;55(8):784-798. doi: 10.1177/0004867420965697. Epub 2020 Oct 22.
PubMed 33092404
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minocycline as an Adjunct for the Treatment of Depressive Symptoms: Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02263872
- Acronym / sponsor ID
- MINDEP001
- Conditions
- Depressive Disorder, Mood Disorders, Depressive Disorder, Treatment Resistant, Antidepressive Agents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Pakistan Institute of Living and LearningUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- Oct 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 13 Oct 2014 (estimated)
- 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.
In this double blind randomised controlled pilot trial the investigators aim to determine the efficacy of minocycline as an adjunct to treatment as usual in patients with major depressive disorder. The investigators hypothesize that the multiple neuroprotective effects of minocycline will lead to an improvement in depressive symptoms in participants that were given minocycline plus treatment as usual
Detailed description
Major depressive disorder is associated with significant morbidity and mortality. According to the WHO, depression is the leading cause of disability worldwide in terms of years lost due to disability [1]. Although depressive symptoms are amenable to antidepressant treatment, a high proportion of patients does not respond or remit. For example in the Sequenced Treatment Alternatives for the Relief of Depression (STAR*D) study the response and remission rates with stage 1 treatment (citalopram) were 49% and 37% respectively and these rates decreased to 16% and 13% respectively over the subsequent next three treatment steps [2]. Clearly there is a need for new treatment approaches.
Recently there has been significant preclinical and clinical study linking inflammatory processes to a range of psychiatric illness including depression, schizophrenia, bipolar disorder and Alzheimer's disease. The evidence that depression is an inflammatory related disorder comes from multiple sources. Depression is associated with raised inflammatory markers even in the absence of a medical illness [3]. More specifically depression has been associated with higher levels of positive acute phase proteins (APPs) and low levels of negative APPs [4] as well as increased levels of complement factors C3c and C4 and immunoglobulin M (IgM) and IgG [5]. Inflammatory medical illness, both CNS and peripheral, are associated with greater rates of depression. In patients with Crohns disease and comorbid depression bouts of physical disease activity tend to co-occur with depressive episodes [6]. Finally, patients treated with cytokines for various illnesses have an increased risk of developing depressive illness [7]. For example, treatment with cytokine IFN-α leads to the development of depressive symptoms in up to 45% of patients [8].
With this in mind it would seem logical to hypothesise that the addition of an anti-inflammatory medication may be a treatment option in depressive illness. Muller et al [9] were successful in showing this when they used Celcoxib in addition to Reboxetine for the treatment of major depressive disorder in a double-blind, randomised, placebo-controlled pilot study. Other studies have shown that TNF (tumour necrosis factor) blocking agents such as Infliximab and Ethanercept improve mood independent of improvement in inflammatory condition [10]. However some studies have found that anti-inflammatories may in fact have an antagonistic effect on the antidepressant actions of SSRIs [11]. Further work is needed in this area to clarify the role of inflammatory processes and anti-inflammatories in the treatment of depression.
Alongside the current interest in the use of anti-inflammatories as novel treatments in psychiatric illness, the antibiotic minocycline has also been proposed for the treatment of depressive symptoms as well as negative symptoms in schizophrenia [12, 13]. Preliminary data from an open label study of patients with psychotic unipolar depression also suggested that minocycline augmentation of antidepressant treatment was effective and well tolerated [14]. Minocycline is a pleiotropic agent that exerts effects on multiple interacting symptoms (e.g. anti-inflammatory, anti-oxidant, anti-apoptotic, anti-gutamatergic, monaminergic) implicated in the pathophysiology of mood disorders. Despite such neuroprotective properties, there have been no clinical trials to date investigating the antidepressant effects of minocycline in individuals. The investigators have previously shown that the addition of minocycline to treatment as usual early in the course of schizophrenia leads to a predominant improvement in negative symptoms.
In this double blind randomised controlled pilot trial the investigators aim to determine the efficacy of minocycline as an adjunct to treatment as usual in patients with major depressive disorder. The investigators hypothesise that the multiple neuroprotective effects of minocycline will lead to an improvement in depressive symptoms in participants that were given minocycline plus treatment as usual.
Aim To investigate whether the addition of minocycline to treatment as usual (TAU) for 3 months in patients with major depressive disorder will lead to an improvement in depressive symptoms compared with TAU.
Methods
Double blind randomised, placebo-controlled pilot trial.
The study will be conducted in Karachi, Pakistan. Patients will be recruited from psychiatric units in Karachi. All patients will give written informed consent after reading information in Urdu, witnessed almost always by a relative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minocycline | Experimental | Drug: MinocyclineMinocycline 200mg perday |
| comparison group with placebo | Placebo comparator | Drug: MinocyclinePlacebo provide |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- patients aged 18-65 years
- Diagnostic and Statistical Manual-IV (DSM-IV) diagnosis of major depressive disorder
- competent and willing to give informed consent
- taking the current antidepressant medication for a minimum of 4 weeks prior to baseline
- the current episode of depression has failed to remit with at least two courses of antidepressant treatment (one of which is the current course)
Key exclusion criteria (10 listed)
- relevant medical illness (renal, hepatic, cardiac, serious dermatological disorders such as exfoliative dermatitis, systemic lupus erythematosis)
- prior history of intolerance to any of the tetracyclines
- concomitant penicillin therapy
- concomitant anticoagulant therapy
- presence of a seizure disorder
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 |
|---|---|---|
| MinocyclineAlso: mesodrumMinocycline 200mg perday | Drug | Minocycline, comparison group with placebo |
Primary outcome
The primary clinical outcome measures will be mean change from baseline on the Hamilton Depression Scale scores
Time frame: 12 weeks
3 secondary outcomes
PHQ-9
Time frame: Baseline, Week 2, week 4, week 8, week 12
GAD-7
Time frame: Baseline, Week 2, week 4, week 8, week 12
CGI
Time frame: Baseline, Week 2, week 4, week 8, week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2016.
- BackgroundWorld Health Organization. The Global Burden of Disease. Geneva: WHO Press; 2012.
- Background: PubMed 17074942Rush AJ, Trivedi MH, Wisniewski SR, Nierenberg AA, Stewart JW, Warden D, Niederehe G, Thase ME, Lavori PW, Lebowitz BD, McGrath PJ, Rosenbaum JF, Sackeim HA, Kupfer DJ, Luther J, Fava M. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006 Nov;163(11):1905-17. doi: 10.1176/ajp.2006.163.11.1905.
- Background: PubMed 23504697O'Donovan A, Rush G, Hoatam G, Hughes BM, McCrohan A, Kelleher C, O'Farrelly C, Malone KM. Suicidal ideation is associated with elevated inflammation in patients with major depressive disorder. Depress Anxiety. 2013 Apr;30(4):307-14. doi: 10.1002/da.22087. Epub 2013 Mar 15.
- Background: PubMed 18073775Dantzer R, O'Connor JC, Freund GG, Johnson RW, Kelley KW. From inflammation to sickness and depression: when the immune system subjugates the brain. Nat Rev Neurosci. 2008 Jan;9(1):46-56. doi: 10.1038/nrn2297.
- Background: PubMed 7516941Song C, Dinan T, Leonard BE. Changes in immunoglobulin, complement and acute phase protein levels in the depressed patients and normal controls. J Affect Disord. 1994 Apr;30(4):283-8. doi: 10.1016/0165-0327(94)90135-x.
- Background: PubMed 15139504Mardini HE, Kip KE, Wilson JW. Crohn's disease: a two-year prospective study of the association between psychological distress and disease activity. Dig Dis Sci. 2004 Mar;49(3):492-7. doi: 10.1023/b:ddas.0000020509.23162.cc.
- Background: PubMed 12661471Van Gool AR, Kruit WH, Engels FK, Stoter G, Bannink M, Eggermont AM. Neuropsychiatric side effects of interferon-alfa therapy. Pharm World Sci. 2003 Feb;25(1):11-20. doi: 10.1023/a:1022449613907.
- Background: PubMed 21334376Capuron L, Miller AH. Immune system to brain signaling: neuropsychopharmacological implications. Pharmacol Ther. 2011 May;130(2):226-38. doi: 10.1016/j.pharmthera.2011.01.014. Epub 2011 Feb 17.
- Background: PubMed 16491133Muller N, Schwarz MJ, Dehning S, Douhe A, Cerovecki A, Goldstein-Muller B, Spellmann I, Hetzel G, Maino K, Kleindienst N, Moller HJ, Arolt V, Riedel M. The cyclooxygenase-2 inhibitor celecoxib has therapeutic effects in major depression: results of a double-blind, randomized, placebo controlled, add-on pilot study to reboxetine. Mol Psychiatry. 2006 Jul;11(7):680-4. doi: 10.1038/sj.mp.4001805. Epub 2006 Feb 21.
- Background: PubMed 22423117Krishnadas R, Cavanagh J. Depression: an inflammatory illness? J Neurol Neurosurg Psychiatry. 2012 May;83(5):495-502. doi: 10.1136/jnnp-2011-301779. Epub 2012 Mar 15.
- Background: PubMed 21518864Warner-Schmidt JL, Vanover KE, Chen EY, Marshall JJ, Greengard P. Antidepressant effects of selective serotonin reuptake inhibitors (SSRIs) are attenuated by antiinflammatory drugs in mice and humans. Proc Natl Acad Sci U S A. 2011 May 31;108(22):9262-7. doi: 10.1073/pnas.1104836108. Epub 2011 Apr 25.
- Background: PubMed 22963995Soczynska JK, Mansur RB, Brietzke E, Swardfager W, Kennedy SH, Woldeyohannes HO, Powell AM, Manierka MS, McIntyre RS. Novel therapeutic targets in depression: minocycline as a candidate treatment. Behav Brain Res. 2012 Dec 1;235(2):302-17. doi: 10.1016/j.bbr.2012.07.026. Epub 2012 Aug 10.
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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.
Dr. Muhammad Ishrat principal investigator
Institute of Psychiatry, Psychology and Neuroscience, Kings college London
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Minocycline in people with Depressive Disorder and Mood Disorders, run by Pakistan Institute of Living and Learning at 3 sites in Pakistan.
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 7 inclusion and 10 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: finished, as of the sponsor's last update on 5 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Pakistan. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary clinical outcome measures will be mean change from baseline on the Hamilton Depression Scale scores (time frame: 12 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 NCT02263872, which also lists 17 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 5 Sep 2016.