Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02907437
Other study ID # 519
Secondary ID
Status Recruiting
Phase Phase 3
First received September 16, 2016
Last updated September 19, 2016
Start date January 2015
Est. completion date January 2018

Study information

Verified date September 2016
Source Beer Yaakov and Ness Ziona Mental Health Center
Contact Rafael Stryjer, MD
Phone +528612945
Email rafael.stryjer@beerness.health.gov.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date January 2018
Est. primary completion date February 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

1. Men and women 18-60 years of age.

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:

1. Patients with acute, unstable, or decompensated medical condition.

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 ß-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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Minocycline
Minocycline as an add-on drug (200 mg/day)
Placebo
(200 mg/day)
Other:
Probiotics
(450 mg/day)

Locations

Country Name City State
Israel Bees Yaakov and Ness Ziona Mental Health Center Beer Yaakov

Sponsors (2)

Lead Sponsor Collaborator
Beer Yaakov and Ness Ziona Mental Health Center Bar-Ilan University, Israel

Country where clinical trial is conducted

Israel, 

References & Publications (10)

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. — View 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. — View 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. Review. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Meyer U, Schwarz MJ, Müller 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. — View Citation

Monji A, Kato T, Kanba S. Cytokines and schizophrenia: Microglia hypothesis of schizophrenia. Psychiatry Clin Neurosci. 2009 Jun;63(3):257-65. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Positive and Negative Syndrome Scale (PANSS) Change in PANSS scores over the 6-weeks study No
Primary Scale for Assessment of Negative Symptoms (SANS) Change in SANS scores over the 6-weeks study No
Secondary Clinical Global Impressions (CGI) Change in CGI scores over the 6-weeks study No
Secondary The Montreal Cognitive Assessment (MoCa) task Change in MoCa scores over the 6-weeks study No
Secondary Trail making task (TMT) Change in TMT scores over the 6-weeks study No
Secondary Empathy Cartoon task Change in Empathy Cartoon task scores over the 6-weeks study No
Secondary Interpersonal Reactivity Index (IRI) Questionnaire Change in IRI scores over the 6-weeks study No
See also
  Status Clinical Trial Phase
Recruiting NCT05039489 - A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia N/A
Completed NCT05111548 - Brain Stimulation and Cognitive Training - Efficacy N/A
Completed NCT05321602 - Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder Phase 1
Completed NCT04503954 - Efficacy of Chronic Disease Self-management Program in People With Schizophrenia N/A
Completed NCT02831231 - Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium Phase 1
Completed NCT05517460 - The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center N/A
Completed NCT03652974 - Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy Phase 4
Recruiting NCT04012684 - rTMS on Mismatch Negativity of Schizophrenia N/A
Recruiting NCT04481217 - Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia N/A
Completed NCT00212784 - Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935) Phase 3
Completed NCT04092686 - A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia Phase 3
Completed NCT01914393 - Pediatric Open-Label Extension Study Phase 3
Recruiting NCT03790345 - Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics Phase 2/Phase 3
Recruiting NCT05956327 - Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training N/A
Terminated NCT03261817 - A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders N/A
Terminated NCT03209778 - Involuntary Memories Investigation in Schizophrenia N/A
Completed NCT02905604 - Magnetic Stimulation of the Brain in Schizophrenia or Depression N/A
Recruiting NCT05542212 - Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia N/A
Completed NCT04411979 - Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia N/A
Terminated NCT03220438 - TMS Enhancement of Visual Plasticity in Schizophrenia N/A