Curcumin Addition to Antipsychotic Treatment in Chronic Schizophrenia Patients
Condition: Chronic Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

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.
    

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.
    

Intervention name(s): Curcumin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3 g/day (3 capsules/day) for 6 months; 3 g/day (3 capsules/day) for 6 months
Other intervention name(s): placebo; regular antipsychotic medication; curcumin; regular antipsychotic medication
Intervention MeSH terms: Curcumin; Antipsychotic Agents
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: curcumin; schizophrenia; neuroprotection