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SchizophreniaPhase 3NCT02907437

Minocycline add-on to Antipsychotics for the Treatment of Negative and Cognitive Symptoms in Schizophrenia

A Phase 3 study testing Minocycline and Probiotics in people with Schizophrenia, run by Beer Yaakov - Ness Ziona Mental Health Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Schizophrenia
What is being tested?
Minocycline and Probiotics
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteIsrael
Study dates
Jan 2015to Jan 2018
Phase
Phase 3
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

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Rafael Stryjer, MD contact

+528612945

rafael.stryjer@beerness.health.gov.il

Netali Mor, MA contact

+972524207260

netalimor@gmail.com

Israel1 site, 1 recruiting

  • Bees Yaakov and Ness Ziona Mental Health Center

    Beer Yaakov

    Rafael Stryjer, MD, +972528612945, rafael.stryjer@beerness.health.gov.il

    Netali Mor, MA, +972524207260, netalimor@gmail.com

    Recruiting

Other trials in Israel

About this study

Official title: Minocycline add-on Medication to Antipsychotics in the Treatment of Schizophrenia Patients: A Double- Blind Randomized Controlled Trial

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.

Conditions
Schizophrenia
Being tested
Minocycline, Placebo, Probiotics
Keywords
Minocycline, Negative symptoms, Cognitive symptoms, Inflammation
Medical subject headings
Schizophrenia, cyclopia sequence, Neurobehavioral Manifestations, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MinocyclineDrug

    Minocycline as an add-on drug (200 mg/day)

  • PlaceboDrug

    (200 mg/day)

  • ProbioticsOther

    (450 mg/day)

Study groups in NCT02907437
Study groupRoleWhat they receive
Minocycline treatmentActive comparatorIntervention: Drug: Minocycline (200 mg/day)
Receives: Drug: Minocycline; Other: Probiotics
Placebo treatmentPlacebo comparatorPlacebo Intervention: Drug: Placebo (200 mg/day)
Receives: Drug: Placebo; Other: Probiotics

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Positive and Negative Syndrome Scale (PANSS)

    Measured: Change in PANSS scores over the 6-weeks study

  2. Scale for Assessment of Negative Symptoms (SANS)

    Measured: Change in SANS scores over the 6-weeks study

Secondary outcomes (5)

  1. Clinical Global Impressions (CGI)

    Measured: Change in CGI scores over the 6-weeks study

  2. The Montreal Cognitive Assessment (MoCa) task

    Measured: Change in MoCa scores over the 6-weeks study

  3. Trail making task (TMT)

    Measured: Change in TMT scores over the 6-weeks study

  4. Empathy Cartoon task

    Measured: Change in Empathy Cartoon task scores over the 6-weeks study

  5. Interpersonal Reactivity Index (IRI) Questionnaire

    Measured: Change in IRI scores over the 6-weeks study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2016 (estimated)
  2. Study startJan 2015
  3. Primary completionFeb 2017 (estimated)
  4. Study completionJan 2018 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02907437
Sponsor's protocol ID
519
Status last verified
Sep 2016
First submitted
16 Sep 2016
Last updated
20 Sep 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 22526685

  • 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.

    PubMed 20138948

  • 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.

    PubMed 24252823

  • 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.

    PubMed 22486246

  • 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.

    PubMed 23487204

  • 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.

    PubMed 24480077

  • 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.

    PubMed 19895780

  • 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.

    PubMed 19579286

  • 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.

    PubMed 25886254

  • 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.

    PubMed 21704074

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Minocycline and Probiotics in people with Schizophrenia, run by Beer Yaakov - Ness Ziona Mental Health Center at 1 site in Israel.

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 15 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 20 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 1 site in Israel. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Rafael Stryjer, MD (+528612945, rafael.stryjer@beerness.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Positive and Negative Syndrome Scale (PANSS) (time frame: Change in PANSS scores over the 6-weeks study). The study lists 2 primary outcomes in all. 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 NCT02907437, which also lists 10 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 20 Sep 2016.

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