Anti-inflammatories and Adolescent Schizophrenia

Schizophrenia Clinical Trial

Official title:

Effect of Anti-inflammatory Treatments on the Symptoms, Cognition, and Functioning of Adolescents With Schizophrenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04020588
• Other study ID #: II3/02/0618
• Status: Recruiting
• Phase: Phase 4
• Start date: February 25, 2019
• Est. completion date: December 2020

Study information

• Verified date: August 2019
• Source: Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico
• Contact: Rosa Ulloa, M.D
• Phone: +525555739161
• Email: eulloa[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A double-blind controlled trial assessing the efficacy of anti-inflammatories on symptoms and cognition of adolescents with schizophrenia

Description:

Patients will be evaluated to confirm the diagnosis of schizophrenia, duration of the disease and record a history of atopic diseases or recurrent infections throughout life. The PANSS, PSP, and MCCB battery scales will be administered. A blood sample will be taken for the determination of markers of inflammation before the start of pharmacological treatment.

Patients will start the antipsychotic medication assigned by their treating physician. They will also be assigned randomly to the treatment arm. The study drug will be provided by the research team under the presentation of capsules containing Celecoxib 200 mg, Minocycline 100 mg or Placebo, and patients will be instructed to take one capsule every 12 hrs daily.

The patient will be reassessed with PANSS, PSP, and MCCB after completing 6 weeks of pharmacological treatment, type and dose of medication will be recorded and serum markers of inflammation will be determined again.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

• Diagnosis of schizophrenia or schizophreniform disorder.

• Patients in their first psychotic episode or previously diagnosed

• No specific pharmacological treatment (antipsychotic at therapeutic doses in regular doses) in the previous two weeks.

• Have a responsible parent or guardian.

Exclusion Criteria:

• Active infection

• Chronic somatic diseases, including autoimmune diseases

• Comorbidity with anorexia, substance use disorders

• Pregnancy

• Use of anti-inflammatory medications or antibiotics

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Celecoxib 200mg
Will be administered for 6 weeks
• Placebo oral capsule
Will be administered for 6 weeks
• Minocycline 100mg
Will be administered for 6 weeks

Locations

Country	Name	City	State
Mexico	Hospital Psiquiatrico Infantil	Mexico City	Ni Ee.uu. Ni Canadá

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Psiquiatrico Infantil Dr. Juan N. Navarro, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom severity: Positive and Negative Syndrome Scale score	Change in the Positive and Negative Syndrome Scale score, which comprises 33 items which can be scored from 1 (absent) to 7 (extreme), evaluating an array of symptoms including positive, negative, neuromotor, depressive and anxious, and involves the use of data from patient reports, caregiver reports, and clinical observations. The total score is the sum or all the items, the maximum score is 231. The higher values represent a worse outcome	six weeks
Primary	Cognition: MATRICS Consensus Cognitive Battery (MCCB) scores	Change in MCCB scores. The MCCB is comprised of 9 tests that reflect 7 dimensions of neurocognitive dysfunction in schizophrenia, including: Speed of Processing, Attention/Vigilance, Working Memory, Verbal Learning, Visual Learning, and Reasoning and Problem Solving and Social Cognition. The MCCB scoring program yields the domain scores and a composite score which are standardized to the same T-score measurement scale with a mean of 50 and an SD of 10 based upon the normative data.	six weeks