Back to resultsMinocycline add-on to Antipsychotics for the Treatment of Negative and Cognitive Symptoms in Schizophrenia
Primary Purpose
Schizophrenia
Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Minocycline
Placebo
Probiotics
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Minocycline, Negative symptoms, Cognitive symptoms, Inflammation
Eligibility Criteria
Inclusion Criteria:
- Men and women 18-60 years of age.
- 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.
- Initiated on treatment with stable dosage (within +/- 25%) of atypical anti-psychotic medication for at least 6 weeks.
- Capable and willing to provide informed consent.
- Able to adhere to the treatment schedule.
- Able to read, hear, write and speak the local language.
- Has signed a written informed consent to participate in the study.
Exclusion Criteria:
- Patients with acute, unstable, or decompensated medical condition.
- Present substance abuse.
- Major depression (MDD) diagnosis.
- Attention deficit/ hyperactivity disorder (ADHD/ADD) diagnosis.
- Cognitive dysfunction, such as Alzheimer disease or retardation.
- Acute psychotic state.
- Aggressive or violent patient or with vast history of aggressive or violent behavior.
- Diagnosis of Borderline/ Anti Social/ Narcissistic personality disorders.
- Previous sensitivity to Minocycline.
- Current suicidal ideation or history of a suicide attempt in the past three years
- 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.
- Subjects who are taking a known contraindication to Minocycline treatment (anti-coagulants, other antibiotics (of the penicillin group), methoxyflurane, Isotretinoin).
- Subjects who had received treatment with Minocycline or β-lactam antibiotics in the preceding half year before study entry.
- Subjects who are under compulsory hospitalization.
- Subjects with medical history of Intestinal disease, Peptic ulcer or gastritis.
Sites / Locations
- Bees Yaakov and Ness Ziona Mental Health CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Minocycline treatment
Placebo treatment
Arm Description
Intervention: Drug: Minocycline (200 mg/day)
Placebo Intervention: Drug: Placebo (200 mg/day)
Outcomes
Primary Outcome Measures
Positive and Negative Syndrome Scale (PANSS)
Scale for Assessment of Negative Symptoms (SANS)
Secondary Outcome Measures
Clinical Global Impressions (CGI)
The Montreal Cognitive Assessment (MoCa) task
Trail making task (TMT)
Empathy Cartoon task
Interpersonal Reactivity Index (IRI) Questionnaire
Full Information
NCT ID
NCT02907437
First Posted
September 16, 2016
Last Updated
September 19, 2016
Sponsor
Beer Yaakov - Ness Ziona Mental Health Center
Collaborators
Bar-Ilan University, Israel
1. Study Identification
Unique Protocol Identification Number
NCT02907437
Brief Title
Minocycline add-on to Antipsychotics for the Treatment of Negative and Cognitive Symptoms in Schizophrenia
Official Title
Minocycline add-on Medication to Antipsychotics in the Treatment of Schizophrenia Patients: A Double- Blind Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
January 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beer Yaakov - Ness Ziona Mental Health Center
Collaborators
Bar-Ilan University, Israel
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Current medications have only a limited effect on two core symptoms of schizophrenia, negative symptoms and cognitive deficits. Minocycline is a second-generation tetracycline which has a beneficial effect in various neurological disorders. In the past years, various findings from clinical studies showed its potential role for the treatment of these symptoms of schizophrenia. The current study aims to examine the efficacy of minocycline as add-on treatment for alleviating positive, negative and cognitive symptoms in schizophrenia patients.The current study is a single center, double-blind, randomized study that assess the adjuvant therapeutic effect of minocycline vs. placebo added to antipsychotic medications, in adult patients suffering from schizophrenia. Patients will be recruited and randomly allocated to a minocycline or placebo treatment (200 mg/day) for 6 weeks of treatment. In addition, all patients will receive probiotics (450mg/day) in order to prevent any gastrointestinal influences of antibiotics administration. Positive and negative symptoms , as well as cognitive functions will be assessed before and after treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Minocycline, Negative symptoms, Cognitive symptoms, Inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Minocycline treatment
Arm Type
Active Comparator
Arm Description
Intervention: Drug: Minocycline (200 mg/day)
Arm Title
Placebo treatment
Arm Type
Placebo Comparator
Arm Description
Placebo Intervention: Drug: Placebo (200 mg/day)
Intervention Type
Drug
Intervention Name(s)
Minocycline
Intervention Description
Minocycline as an add-on drug (200 mg/day)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
(200 mg/day)
Intervention Type
Other
Intervention Name(s)
Probiotics
Intervention Description
(450 mg/day)
Primary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale (PANSS)
Time Frame
Change in PANSS scores over the 6-weeks study
Title
Scale for Assessment of Negative Symptoms (SANS)
Time Frame
Change in SANS scores over the 6-weeks study
Secondary Outcome Measure Information:
Title
Clinical Global Impressions (CGI)
Time Frame
Change in CGI scores over the 6-weeks study
Title
The Montreal Cognitive Assessment (MoCa) task
Time Frame
Change in MoCa scores over the 6-weeks study
Title
Trail making task (TMT)
Time Frame
Change in TMT scores over the 6-weeks study
Title
Empathy Cartoon task
Time Frame
Change in Empathy Cartoon task scores over the 6-weeks study
Title
Interpersonal Reactivity Index (IRI) Questionnaire
Time Frame
Change in IRI scores over the 6-weeks study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and women 18-60 years of age.
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.
Initiated on treatment with stable dosage (within +/- 25%) of atypical anti-psychotic medication for at least 6 weeks.
Capable and willing to provide informed consent.
Able to adhere to the treatment schedule.
Able to read, hear, write and speak the local language.
Has signed a written informed consent to participate in the study.
Exclusion Criteria:
Patients with acute, unstable, or decompensated medical condition.
Present substance abuse.
Major depression (MDD) diagnosis.
Attention deficit/ hyperactivity disorder (ADHD/ADD) diagnosis.
Cognitive dysfunction, such as Alzheimer disease or retardation.
Acute psychotic state.
Aggressive or violent patient or with vast history of aggressive or violent behavior.
Diagnosis of Borderline/ Anti Social/ Narcissistic personality disorders.
Previous sensitivity to Minocycline.
Current suicidal ideation or history of a suicide attempt in the past three years
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.
Subjects who are taking a known contraindication to Minocycline treatment (anti-coagulants, other antibiotics (of the penicillin group), methoxyflurane, Isotretinoin).
Subjects who had received treatment with Minocycline or β-lactam antibiotics in the preceding half year before study entry.
Subjects who are under compulsory hospitalization.
Subjects with medical history of Intestinal disease, Peptic ulcer or gastritis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rafael Stryjer, MD
Phone
+528612945
Email
rafael.stryjer@beerness.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Netali Mor, MA
Phone
+972524207260
Email
netalimor@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafael Stryjer, MD
Organizational Affiliation
Beer Yaakov - Ness Ziona Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bees Yaakov and Ness Ziona Mental Health Center
City
Beer Yaakov
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafael Stryjer, MD
Phone
+972528612945
Email
rafael.stryjer@beerness.health.gov.il
First Name & Middle Initial & Last Name & Degree
Netali Mor, MA
Phone
+972524207260
Email
netalimor@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22526685
Citation
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.
Results Reference
background
PubMed Identifier
20138948
Citation
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.
Results Reference
background
PubMed Identifier
24252823
Citation
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.
Results Reference
background
PubMed Identifier
22486246
Citation
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.
Results Reference
background
PubMed Identifier
23487204
Citation
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.
Results Reference
background
PubMed Identifier
24480077
Citation
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.
Results Reference
background
PubMed Identifier
19895780
Citation
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.
Results Reference
background
PubMed Identifier
19579286
Citation
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.
Results Reference
background
PubMed Identifier
25886254
Citation
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.
Results Reference
background
PubMed Identifier
21704074
Citation
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.
Results Reference
background
Learn more about this trial
Minocycline add-on to Antipsychotics for the Treatment of Negative and Cognitive Symptoms in Schizophrenia
We'll reach out to this number within 24 hrs