Minocycline add-on to Antipsychotics for the Treatment of Negative and Cognitive Symptoms in Schizophrenia
NCT ID: NCT02907437
Last Updated: 2016-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
40 participants
INTERVENTIONAL
2015-01-31
2018-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Minocycline treatment
Intervention: Drug: Minocycline (200 mg/day)
Minocycline
Minocycline as an add-on drug (200 mg/day)
Probiotics
(450 mg/day)
Placebo treatment
Placebo Intervention: Drug: Placebo (200 mg/day)
Placebo
(200 mg/day)
Probiotics
(450 mg/day)
Interventions
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Minocycline
Minocycline as an add-on drug (200 mg/day)
Placebo
(200 mg/day)
Probiotics
(450 mg/day)
Eligibility Criteria
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Inclusion Criteria
2. Diagnostic and Statistical Manual (DSM) 5 diagnosis of Schizophrenia/ Schizo effective disorder based on the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID) for schizophrenia and confirmed by two senior psychiatrists.
3. Initiated on treatment with stable dosage (within +/- 25%) of atypical anti-psychotic medication for at least 6 weeks.
4. Capable and willing to provide informed consent.
5. Able to adhere to the treatment schedule.
6. Able to read, hear, write and speak the local language.
7. Has signed a written informed consent to participate in the study.
Exclusion Criteria
2. Present substance abuse.
3. Major depression (MDD) diagnosis.
4. Attention deficit/ hyperactivity disorder (ADHD/ADD) diagnosis.
5. Cognitive dysfunction, such as Alzheimer disease or retardation.
6. Acute psychotic state.
7. Aggressive or violent patient or with vast history of aggressive or violent behavior.
8. Diagnosis of Borderline/ Anti Social/ Narcissistic personality disorders.
9. Previous sensitivity to Minocycline.
10. Current suicidal ideation or history of a suicide attempt in the past three years
11. Known or suspected pregnancy or women of childbearing potential not using a medically accepted form of contraception .(if using oral contraceptives, during the Minocycline treatment, subject should use an additional contraceptives), or women who are breastfeeding.
12. Subjects who are taking a known contraindication to Minocycline treatment (anti-coagulants, other antibiotics (of the penicillin group), methoxyflurane, Isotretinoin).
13. Subjects who had received treatment with Minocycline or β-lactam antibiotics in the preceding half year before study entry.
14. Subjects who are under compulsory hospitalization.
15. Subjects with medical history of Intestinal disease, Peptic ulcer or gastritis.
18 Years
60 Years
ALL
No
Sponsors
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Bar-Ilan University, Israel
OTHER
Beer Yaakov - Ness Ziona Mental Health Center
OTHER_GOV
Responsible Party
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Dr. Stryjer Rafael (MD)
Senior Psychatrist
Principal Investigators
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Rafael Stryjer, MD
Role: PRINCIPAL_INVESTIGATOR
Beer Yaakov - Ness Ziona Mental Health Center
Locations
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Bees Yaakov and Ness Ziona Mental Health Center
Beer Yaakov, , Israel
Countries
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Central Contacts
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Facility Contacts
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References
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Chaudhry 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.
Chaves C, de Marque CR, Wichert-Ana L, Maia-de-Oliveira JP, Itikawa EN, Crippa JA, Zuardi AW, Todd KG, Baker GB, Dursun SM, Hallak JE. Functional neuroimaging of minocycline's effect in a patient with schizophrenia. Prog Neuropsychopharmacol Biol Psychiatry. 2010 Apr 16;34(3):550-2. doi: 10.1016/j.pnpbp.2010.01.020. Epub 2010 Feb 6. No abstract available.
Davis MC, Horan WP, Marder SR. Psychopharmacology of the negative symptoms: current status and prospects for progress. Eur Neuropsychopharmacol. 2014 May;24(5):788-99. doi: 10.1016/j.euroneuro.2013.10.010. Epub 2013 Nov 4.
Dean OM, Data-Franco J, Giorlando F, Berk M. Minocycline: therapeutic potential in psychiatry. CNS Drugs. 2012 May 1;26(5):391-401. doi: 10.2165/11632000-000000000-00000.
Jhamnani K, Shivakumar V, Kalmady S, Rao NP, Venkatasubramanian G. Successful use of add-on minocycline for treatment of persistent negative symptoms in schizophrenia. J Neuropsychiatry Clin Neurosci. 2013 Winter;25(1):E06-7. doi: 10.1176/appi.neuropsych.11120376. No abstract available.
Khodaie-Ardakani MR, Mirshafiee O, Farokhnia M, Tajdini M, Hosseini SM, Modabbernia A, Rezaei F, Salehi B, Yekehtaz H, Ashrafi M, Tabrizi M, Akhondzadeh S. Minocycline add-on to risperidone for treatment of negative symptoms in patients with stable schizophrenia: randomized double-blind placebo-controlled study. Psychiatry Res. 2014 Mar 30;215(3):540-6. doi: 10.1016/j.psychres.2013.12.051. Epub 2014 Jan 9.
Levkovitz Y, Mendlovich S, Riwkes S, Braw Y, Levkovitch-Verbin H, Gal G, Fennig S, Treves I, Kron S. A double-blind, randomized study of minocycline for the treatment of negative and cognitive symptoms in early-phase schizophrenia. J Clin Psychiatry. 2010 Feb;71(2):138-49. doi: 10.4088/JCP.08m04666yel. Epub 2009 Nov 3.
Monji A, Kato T, Kanba S. Cytokines and schizophrenia: Microglia hypothesis of schizophrenia. Psychiatry Clin Neurosci. 2009 Jun;63(3):257-65. doi: 10.1111/j.1440-1819.2009.01945.x.
Lisiecka DM, Suckling J, Barnes TR, Chaudhry IB, Dazzan P, Husain N, Jones PB, Joyce EM, Lawrie SM, Upthegrove R, Deakin B. The benefit of minocycline on negative symptoms in early-phase psychosis in addition to standard care - extent and mechanism (BeneMin): study protocol for a randomised controlled trial. Trials. 2015 Mar 2;16:71. doi: 10.1186/s13063-015-0580-x.
Meyer U, Schwarz MJ, Muller N. Inflammatory processes in schizophrenia: a promising neuroimmunological target for the treatment of negative/cognitive symptoms and beyond. Pharmacol Ther. 2011 Oct;132(1):96-110. doi: 10.1016/j.pharmthera.2011.06.003. Epub 2011 Jun 15.
Other Identifiers
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519
Identifier Type: -
Identifier Source: org_study_id
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