NCT02298985

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2015

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 24, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

2 years

First QC Date

November 18, 2014

Last Update Submit

January 14, 2019

Conditions

Chronic Schizophrenia

Keywords

curcumin; schizophrenia; neuroprotection

Outcome Measures

Primary Outcomes (1)

  • Positive and Negative Symptoms Scale (PANSS)

    baseline and every week 4 up to 24 weeks

    up to 24 weeks

Secondary Outcomes (3)

  • Clinical Global Impression - Improvement (CGI-I)

    up to 24 weeks

  • Clinical Global Impression - Severity of Adverse Events (CGI-SAE)

    up to 24 weeks

  • Calgary Depression Scale for Schizophrenia (CDSS)

    up to 24 weeks

Study Arms (2)

curcumin

ACTIVE COMPARATOR

curcumin 3 g/day for 6 months

Drug: CurcuminDrug: placebo

placebo

PLACEBO COMPARATOR

curcumin 3 g/day for 6 months

Drug: CurcuminDrug: placebo

Interventions

CurcuminDRUG

3 g/day (3 capsules/day) for 6 months

Also known as: placebo, regular antipsychotic medication
curcuminplacebo
placeboDRUG

3 g/day (3 capsules/day) for 6 months

Also known as: curcumin, regular antipsychotic medication
curcuminplacebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beersheva Mental Health Center

Beersheva, Israel

Location

Tirat Carmel Mental Health Center

Tirat Carmel, 84170, Israel

Location

Related Publications (1)

  • Miodownik C, Lerner V, Kudkaeva N, Lerner PP, Pashinian A, Bersudsky Y, Eliyahu R, Kreinin A, Bergman J. Curcumin as Add-On to Antipsychotic Treatment in Patients With Chronic Schizophrenia: A Randomized, Double-Blind, Placebo-Controlled Study. Clin Neuropharmacol. 2019 Jul/Aug;42(4):117-122. doi: 10.1097/WNF.0000000000000344.

    PMID: 31045590DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Vladimir Lerner, MD, PhD

    Ben-Gurion University of the Negev

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 18, 2014

First Posted

November 24, 2014

Study Start

January 1, 2015

Primary Completion

January 1, 2017

Study Completion

May 1, 2017

Last Updated

January 15, 2019

Record last verified: 2019-01

Locations

IL(2)