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Trial record 31 of 4749 for:    Recruiting, Not yet recruiting, Available Studies | "Psychotic Disorders"

Aspirin in Young Psychotic Patients

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ClinicalTrials.gov Identifier: NCT02685748
Recruitment Status : Recruiting
First Posted : February 19, 2016
Last Update Posted : August 9, 2017
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Dragana Pavićević, Clinic for Psychiatric Disorders, Dr Laza Lazarevic

Brief Summary:
In this double blind randomized clinical trial the investigators are going to exam influence of adjuvant Aspirin therapy on soft neurological signs (Heidelberg scale), positive and negative symptoms (PANSS), cytokine profile and inflammatory factors, as well as on cognition (MoCA) in young psychotic patients.

Condition or disease Intervention/treatment Phase
Psychosis Acute Psychosis Schizophrenia Drug: Aspirin Drug: Placebo Drug: Pantoprazole Phase 2 Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Aspirin as Adjuvant Therapy in Young Psychotic Patients
Actual Study Start Date : July 20, 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aspirin & pantoprazole

Aspirin 1000 mg/pd per os in two doses

Pantoprazole 40 mg/pd per os in two doses for gastric protection

Drug: Aspirin
1000 mg pd in two doses
Other Name: Acetylsalicylic acid

Drug: Pantoprazole
Pantoprazole 40 mg/pd in two doses, for gastric protection
Other Names:
  • Protonix
  • Controloc

Placebo Comparator: Placebo

Two pills in the morning and two in the evening

All pills (aspirin, pantoprazole an placebo) will be the same looking- in the same capsules.

Drug: Placebo
two pills twice a day (instead of aspirin and pantoprazole)
Other Name: sugar pill




Primary Outcome Measures :
  1. Changes of Soft Neurological Signs [ Time Frame: Change from baseline after six weeks of treatment ]
    NSS will be assessed by Heidelberg NSS Scale, 16 items scale (motor coordination, integrative functions, complex motor tasks, orientation, hard signs)


Secondary Outcome Measures :
  1. Changes of psychopathology [ Time Frame: Change after six weeks of treatment from baseline ]
    PANSS total, positive, negative and general psychopathology scores

  2. Change of Cognition [ Time Frame: Change after six weeks of treatment from baseline ]
    MoCA scale scores

  3. Change of marker of inflammation- CRP [ Time Frame: Change after six weeks of treatment from baseline ]
    Change of C-reactive protein (CRP) after 6 week of treatment

  4. Change of marker of inflammation- WBC [ Time Frame: Change after six weeks of treatment from baseline ]
    Change of White Blood Cells count after 6 week of treatment

  5. Change of Cytokine profile- Th1 [ Time Frame: Change after six weeks of treatment from baseline ]
    Change of Th1 immune response

  6. Change of Cytokine profile- Th2 [ Time Frame: Change after six weeks of treatment from baseline ]
    Change of Th2 immune response

  7. Change of Cytokine profile- type 17 [ Time Frame: Change after six weeks of treatment from baseline ]
    Change of Type-17 immune response



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Ages Eligible for Study:   18 Years to 28 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 to 28 years of life
  • diagnostic categories from F 20 to F 29, according to ICD 10 criteria
  • duration of illness ≤ 7 years

Exclusion Criteria:

  • Substance abuse
  • Primary cognitive impairment
  • Contraindications and special caution for acetylsalicylic acid and pantoprazole: hypersensitivity to aspirin and other NSAIDs or pantoprazole, ulcers, gastritis, pregnancy, haemophilia, bleeding disorders, gout, asthma, COPD, bronchospasm induced by NSAIDs, angioedema, urticaria, haemolytic anaemia, use of warfarin or methotrexate, diabetes, reduced function of liver and/or kidney, heart failure, surgical/dental intervention, interactions with certain psychotropic drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02685748


Contacts
Contact: Dragana Pavićević, psychiatrist 65.2207970 ext +381 gagapavicevic@yahoo.com
Contact: Đorđe Ćurčić, psychiatrist dzordzic@yahoo.com

Locations
Serbia
Clinic for psychiatric disorders Dr Laza Lazarevic Recruiting
Belgrade, Serbia, 11000
Contact: Slavica Djukic Dejanovic, Prof.         
Contact: Djordje Curcic, MD         
Principal Investigator: Dragana Pavicevic, MD         
Sub-Investigator: Slavica Djukic Dejanovic, Professor         
Sub-Investigator: Djordje Curcic, MD         
Sub-Investigator: Nebojsa Zivkovic, MD         
Sponsors and Collaborators
Clinic for Psychiatric Disorders, Dr Laza Lazarevic
Stanley Medical Research Institute
Investigators
Principal Investigator: Dragana Pavićević, psychiatrist Emergency Department & Intensive Care Unit, Clinic for psychiatric disorder Dr Laza Lazarević
Study Director: Slavica Đukić Dejanović, Prof, neuropsychiatrist Director of Clinic for psychiatric disorder Dr Laza Lazarević

Additional Information:
Publications:

Responsible Party: Dragana Pavićević, Dr Dragana Pavicevic, Clinic for Psychiatric Disorders, Dr Laza Lazarevic
ClinicalTrials.gov Identifier: NCT02685748     History of Changes
Other Study ID Numbers: #15T-006
First Posted: February 19, 2016    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Schizophrenia
Aspirin
Pantoprazole
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors