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RCT of Methotrexate Added to Treatment As Usual in Schizophrenia (RECOVERY)

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ClinicalTrials.gov Identifier: NCT02074319
Recruitment Status : Completed
First Posted : February 28, 2014
Last Update Posted : September 22, 2015
Sponsor:
Collaborators:
Abbasi Shaheed Hospital
Dow University of Health Sciences
Karwan e Hayat, Karachi, Pakistan
Institute of Behavioural Sciences, Karachi, Pakistan
Information provided by (Responsible Party):
Pakistan Institute of Living and Learning

Brief Summary:
The aim of the this study is to evaluate the effectiveness of methotrexate added to treatment as usual on positive and negative symptoms, cognitive and social functioning and quality of life of patients suffering from schizophrenia.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Schizophreniform Disorder Drug: Methotrexate Phase 1

Detailed Description:

The purpose of the study is to test the prediction that addition of methotrexate to treatment as usual (TAU) for patients with schizophrenia will result in following outcomes:

  • Primary:

    • improvement in negative symptoms
    • improvement in positive symptoms
  • Secondary:

    • improvement in social functioning
    • improvement in cognitive functions
    • acceptability and tolerability of methotrexate added to TAU A total 72 participants (36 participants in intervention group and 36 in control group) meeting inclusion criteria of the study will be recruited and randomized in study in two arms. Research assistants and participating psychiatrists will assess participants for eligibility criteria. After providing detailed information regarding study by using patient information sheet, written informed consent will be taken from participants. Trained research assistant will asses participants at baseline, 2, 4, 6 and 12 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Double Blind Placebo Controlled 12 Week Trial of Methotrexate Added to Treatment As Usual in Early Schizophrenia
Study Start Date : December 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Placebo Comparator: Placebo
Matching placebo for methotrexate
Drug: Methotrexate
Treatment as usual or standard treatment for psychosis will be common in all arms

Experimental: Methotrexate
Methotrexate 10 mg once a week orally
Drug: Methotrexate
Treatment as usual or standard treatment for psychosis will be common in all arms




Primary Outcome Measures :
  1. Positive and Negative Syndrome Scale PANSS [ Time Frame: 3 months ]
    PANSS is an assessment measures to assess severity of symptoms of schizophrenia


Secondary Outcome Measures :
  1. CogState [ Time Frame: 3 months ]
    Measuring all seven domains recommended by MATRICS (NIMH initiative). These domains include speed processing, attention/vigilance, Working memory (nonverbal & verbal), verbal learning, visual learning, reasoning and problem solving and social cognitions.


Other Outcome Measures:
  1. Social Functioning Scale [ Time Frame: 3 months ]
    Self-rating questionnaire assessing social functioning in 7 domains.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent, indicating that the subject understood the purpose of and procedures required for the study, before the initiation of any study specific procedures
  • Aged 18 to 35 years
  • Diagnostic and Statistical Manual-IV (DSM-IV) diagnosed first episode psychosis, schizophrenia, schizoaffective disorder, psychosis not otherwise specified or schizophreniform disorder.
  • First episode (within first 5 years of diagnosis)
  • Competent and willing to give informed consent
  • Medication remained stable 4 weeks prior to baseline.
  • Able to take oral medication and likely to complete the required evaluations.
  • Female participants of child bearing capability must be willing to use adequate contraceptives for the duration of the study, and, willing to have a pregnancy test pre treatment and at ten weekly intervals while on study medication.

    1. Adequate contraception is defined as use of contraceptive double barrier system (i.e. condom and spermicide) or contraceptive implant, oral contraceptive or injected depot contraceptive plus other form of contraceptive i.e. condom. Females will be considered incapable of child bearing if they are one year post-menopausal or irreversibly surgically sterilised.

Exclusion Criteria:

  • Violation of any inclusion criteria
  • Failure to perform screening or baseline examinations
  • Relevant ICD 10 organic brain disease or neurological diagnoses
  • Patients with liver disease
  • Patients who will meet the criteria for a DSM-IV TR diagnosis of alcohol or substance abuse (other than for nicotine) within the last month or the criteria for DSM-IV TR alcohol or substance dependence (other than for nicotine) within the last 6 months
  • Any change of psychotropic medications within the previous 4 weeks
  • Recreational drugs or alcohol abuse
  • Pregnant or lactating women and those of reproductive age without adequate contraception
  • Relevant medical illness will be determined in the first instance by asking the patients mental health care team if the patient has any medical condition/problems. After consent has been obtained the research nurse/ research doctor will then have access to the patients' notes and will assess patient eligibility to take part in the clinical trial by scrutinising the patients' past medical history, most recent blood results, electrocardiograms, as well as any physical tests that have been performed on the patient.

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): NCT02074319


Locations
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Pakistan
Abasi Shaheed Hospital
Karachi, Sindh, Pakistan, 72000
Civil hospital Karachi
Karachi, Sindh, Pakistan, 72000
Institute of Behavioural Sciences
Karachi, Sindh, Pakistan, 72000
Karwn e Hayat
Karachi, Sindh, Pakistan, 72000
Sponsors and Collaborators
Pakistan Institute of Living and Learning
Abbasi Shaheed Hospital
Dow University of Health Sciences
Karwan e Hayat, Karachi, Pakistan
Institute of Behavioural Sciences, Karachi, Pakistan
Investigators
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Principal Investigator: Prof Imran B Chaudhry, MD University of Manchester
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pakistan Institute of Living and Learning
ClinicalTrials.gov Identifier: NCT02074319    
Other Study ID Numbers: RECOVERY-001
First Posted: February 28, 2014    Key Record Dates
Last Update Posted: September 22, 2015
Last Verified: September 2015
Keywords provided by Pakistan Institute of Living and Learning:
Schizophrenia
Anti-Inflammatory
Methotrexate
Psychosis Not Otherwise Specified
Additional relevant MeSH terms:
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Disease
Schizophrenia
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors