Clinical trial NCT02907437: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Minocycline
Negative symptoms
Cognitive symptoms
Inflammation
Lead sponsor: Beer Yaakov - Ness Ziona Mental Health Center
Sponsor class: OTHER_GOV
Collaborators: name: Bar-Ilan University, Israel
First posted: 2016-09-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 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.

Primary outcomes:
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: Change in PANSS scores over the 6-weeks study
measure: Scale for Assessment of Negative Symptoms (SANS)
timeFrame: Change in SANS scores over the 6-weeks study
Secondary outcomes:
measure: Clinical Global Impressions (CGI)
timeFrame: Change in CGI scores over the 6-weeks study
measure: The Montreal Cognitive Assessment (MoCa) task
timeFrame: Change in MoCa scores over the 6-weeks study
measure: Trail making task (TMT)
timeFrame: Change in TMT scores over the 6-weeks study
measure: Empathy Cartoon task
timeFrame: Change in Empathy Cartoon task scores over the 6-weeks study
measure: Interpersonal Reactivity Index (IRI) Questionnaire
timeFrame: Change in IRI scores over the 6-weeks study
Other outcomes:
Locations:
city: Beer Yaakov
country: Israel
facility: Bees Yaakov and Ness Ziona Mental Health Center
Study officials:
affiliation: Beer Yaakov - Ness Ziona Mental Health Center
name: Rafael Stryjer, MD
role: PRINCIPAL_INVESTIGATOR
References:
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