A Pilot Trial of Curcumin Effects on Cognition in Schizophrenia

NCT ID: NCT02476708

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-11
• Study Completion Date: 2017-08-24

Brief Summary

This is an 8-week randomized, double-blind, placebo-controlled, parallel, fixed-dose pilot clinical trial of curcumin for the treatment of cognitive impairment in schizophrenia.The primary aim of this pilot trial is to provide an effect size estimate for the efficacy of curcumin in improving cognitive functioning in schizophrenia. Secondary goals are to determine the effect of curcumin over time on negative and positive symptoms, in association with inflammatory markers.

Detailed Description

This is an 8-week randomized, double-blind, placebo-controlled, parallel, fixed-dose pilot clinical trial of curcumin for the treatment of cognitive impairment in schizophrenia. Cognitive impairment and persistent negative symptoms are the core dimensions of schizophrenia; however current antipsychotic treatment fails to address this issue. Evidence suggests cognitive impairment is not only limited to patients with late-stage schizophrenia. High rates of cognitive impairment in patients with first episode psychosis indicate that cognitive impairment is not solely a consequence of long-term antipsychotic treatment, but rather is an enduring problem over the course of schizophrenia. Likewise, negative symptoms persist throughout its entire course, and are associated with poor overall functioning. Currently, there are no pharmacological agents that specifically aim to treat cognitive functioning and persistent negative symptoms; therefore, there is growing interest in the development of effective treatments for this unmet need.

The primary aim of this pilot trial is to provide an effect size estimate for the efficacy of curcumin in improving cognitive functioning in schizophrenia. Secondary goals are to determine the effect of curcumin over time on negative and positive symptoms, in association with inflammatory markers. Eligible participants will be randomized to curcumin (n=20) or placebo (n=20) in a 1:1 ratio. A commercially available surface-controlled water soluble form of 600mg curcumin (10% formulation) or matching placebo capsules will be administered three times a day for a total of 8 weeks.

Conditions

Schizophrenia; Schizoaffective Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Curcumin 1800mg

curcumin capsule 600mg taken 3 times per day for 8 weeks

Group Type: EXPERIMENTAL

curcumin 1800mg

Intervention Type: DIETARY_SUPPLEMENT

Curcumin, derived from turmeric root, is an over-the-counter supplement which is tolerated well.

Placebo

placebo capsule taken 3 times per day for 8 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

oral placebo capsule

Interventions

curcumin 1800mg

Curcumin, derived from turmeric root, is an over-the-counter supplement which is tolerated well.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

oral placebo capsule

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

theracurmin

Eligibility Criteria

Inclusion Criteria

1. 18 - 65 years of age

2. English speaking

3. Diagnostic and Statistical Manual- IV diagnosis of schizophrenia or schizoaffective disorder based on Structured Clinical Interview for Diagnostic and Statistical Manual-IV (SCID)

4. Symptomatic stability confirmed by clinical staff in the 8 weeks prior to the study

5. No changes in antipsychotic medication within the last 8 weeks

6. No change in antipsychotic dose in in last 4 weeks.

Exclusion Criteria

1. Unable to provide informed consent

2. Diagnostic and Statistical Manual-IV (DSM-IV) diagnosis of alcohol/substance dependence

3. Recent history of gastrointestinal bleeding or ulceration

4. Recent history of gallstones and/or bile duct obstruction

5. Significant uncontrolled systemic illness (e.g. chronic renal failure, chronic liver disease, poorly controlled diabetes, poorly controlled congestive heart failure, chronic infectious disease, chronic autoimmune disease)

6. Known intolerance to turmeric, curcumin, or curry

7. Pregnancy or breast-feeding

8. Current use of anti-platelet, anti-coagulant, glucocorticoid, immunosuppressants

9. Daily use of non-steroidal anti-inflammatory use.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Cenk Tek

Associate Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cenk Tek, MD

Role: PRINCIPAL_INVESTIGATOR

Yale Unversity School of Medicine

Locations

Connecticut Mental Health Center

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

1412015121

Identifier Type: -

Identifier Source: org_study_id