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Curcumin Addition to Antipsychotic Treatment in Chronic Schizophrenia Patients

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ClinicalTrials.gov Identifier: NCT02298985
Recruitment Status : Unknown
Verified January 2016 by Vladimir Lerner, Beersheva Mental Health Center.
Recruitment status was:  Recruiting
First Posted : November 24, 2014
Last Update Posted : January 13, 2016
Sponsor:
Collaborator:
Tirat Carmel Mental Health Center
Information provided by (Responsible Party):
Vladimir Lerner, Beersheva Mental Health Center

Brief Summary:
Schizophrenia is still remained one of the disabling disorders despite progress in treatment of mental disturbances. Ten to thirty percents of patients have a little or no benefit from treatment with all kinds of antipsychotics using adequate dosages and duration. Treatment of these patients has remained a persistent public health problem since medication-resistant patients are often highly symptomatic. Curcumin is one of the main curcuminoids isolated from this perennial herb. It possesses a variety of pharmacological activities, including anti-inflammatory, antiproliferative, antioxidant, and neuroprotective effects and crosses the blood-brain barrier. The purpose of our suggested study is to examine the efficacy of curcumin as add-on the conventional antipsychotic psychopharmacotherapy in chronic schizophrenia patients.

Condition or disease Intervention/treatment Phase
Chronic Schizophrenia Drug: Curcumin Drug: placebo Phase 4

Detailed Description:

Study Design This is a 24-week, randomized, double-blind, placebo-controlled investigation of 40 chronic schizophrenia patients.

Participants Forty patients will be drawn from the patient population of Be'er Sheva Mental Health Center. Recruitment period will last over 2 years.

Patients will be required to have a primary diagnosis of chronic schizophrenia as defined in DSM-IV with predominantly persistent negative signs.

The study will commence only after approval by the local Institutional Ethics Review Board ("Helsinki Committee"). Only willing subjects and able to provide written informed consent, after receiving a comprehensive explanation of the study procedures, will be included in the study. Confidentially will be ensured by means of a number coding system, and all completed research forms will be stored in secure areas.

Procedure Patients will continue receiving their regular antipsychotic medication. The dose will be kept constant for at least 3 months prior to entry and throughout the study period. Curcumin is provided as Curcumin Forte ® (Solgar Israel SupHerb). Circumin capsules are supplied as an 1000 mg soft gelatin capsule for three daily oral administration with meals. At entry patients will receive curcuma capsules (3000 mg/day, three capsules) or placebo in identical capsules in a randomized, double blind mode for 24 weeks: 20 patients will receive curcumin, and 20 patients - placebo.

Participants will be assessed at baseline and after 4, 8, 12, 16 and 24 weeks of treatment. In a case of treatment discontinuation for 24-week of the trial, patients will be followed until end of study period.

Outcome variables will be evaluated by scoring the severity of symptoms (positive, negative, and etc.), and side effects. In addition, liver function tests and a blood cell count will be monitored at baseline and during the study.

For analyzing the results, within-subject pre- and post-treatment responses would be subject to statistical procedures to evaluate whether curcumin can ameliorate the persistent negative symptoms in schizophrenia.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Curcumin as add-on to Antipsychotic Treatment in Chronic Schizophrenia Patients: A Randomized, Double-Blind, Placebo-controlled Study
Study Start Date : January 2015
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Curcumin
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: curcumin
curcumin 3 g/day for 6 months
Drug: Curcumin
3 g/day (3 capsules/day) for 6 months
Other Names:
  • placebo
  • regular antipsychotic medication
Drug: placebo
3 g/day (3 capsules/day) for 6 months
Other Names:
  • curcumin
  • regular antipsychotic medication
Placebo Comparator: placebo
curcumin 3 g/day for 6 months
Drug: Curcumin
3 g/day (3 capsules/day) for 6 months
Other Names:
  • placebo
  • regular antipsychotic medication
Drug: placebo
3 g/day (3 capsules/day) for 6 months
Other Names:
  • curcumin
  • regular antipsychotic medication



Primary Outcome Measures :
  1. Positive and Negative Symptoms Scale (PANSS) [ Time Frame: up to 24 weeks ]
    baseline and every week 4 up to 24 weeks


Secondary Outcome Measures :
  1. Clinical Global Impression - Improvement (CGI-I) [ Time Frame: up to 24 weeks ]
    baseline and every week 4 up to 24 weeks

  2. Clinical Global Impression - Severity of Adverse Events (CGI-SAE) [ Time Frame: up to 24 weeks ]
    baseline and every week 4 up to 24 weeks

  3. Calgary Depression Scale for Schizophrenia (CDSS) [ Time Frame: up to 24 weeks ]
    baseline and every week 4 up to 24 weeks



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-60 years, male or female
  • DSM-IV criteria for schizophrenia.
  • Ability and willingness to sign informed consent for participation in the study
  • SANS (Scale of Negative Symptoms of Schizophrenia ) > 30 points
  • Fixed antipsychotic dosages at least 3 months
  • Steady mental state of patients at least 3 months

Exclusion Criteria:

  • Current substance use disorder except nicotine dependence
  • Regular use of NSAID (non-steroidal anti-inflammatory drugs)
  • Cancer history
  • Untreated or severe hypertension
  • Poorly controlled diabetes mellitus Type I or Type II
  • Chronic liver & gallbladder diseases
  • Recent GERD (Gastroesophageal Reflux Disorder)
  • Neurological disorders: epilepsy, stroke
  • Hamilton Depression Scale Hamilton Depression Rating Scale (HAM-D-17 item) > 24 points
  • Patients with a known hypersensitivity to curcumin
  • Pregnant women or a woman who intends to become pregnant

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): NCT02298985


Contacts
Contact: Vladimir Lerner, MD, PhD +97286401408 lernervld@yahoo.com
Contact: Joseph Bergman, MD +97248263532 jbergman1983@yahoo.com

Locations
Israel
Beersheva Mental Health Center Recruiting
Beersheva, Israel
Contact: Vladimir Lerner, MD, PhD    972-8-6401408    lernervld@yahoo.com   
Principal Investigator: Vladimir Lerner, MD, PhD         
Tirat Carmel Mental Health Center Recruiting
Tirat Carmel, Israel, 84170
Contact: Joseph Bergman, MD    +97248559287    jbergman1983@yahoo.com   
Contact: Vladimir Lerner, MD, PhD    +972 8 6401408    lernervld@yahoo.com   
Sponsors and Collaborators
Beersheva Mental Health Center
Tirat Carmel Mental Health Center
Investigators
Principal Investigator: Vladimir Lerner, MD, PhD Ben-Gurion University of the Negev

Responsible Party: Vladimir Lerner, Associate Professor, Beersheva Mental Health Center
ClinicalTrials.gov Identifier: NCT02298985     History of Changes
Other Study ID Numbers: VLJB-14
First Posted: November 24, 2014    Key Record Dates
Last Update Posted: January 13, 2016
Last Verified: January 2016

Keywords provided by Vladimir Lerner, Beersheva Mental Health Center:
curcumin; schizophrenia; neuroprotection

Additional relevant MeSH terms:
Curcumin
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action