Clinical trial NCT02476708: A Pilot Trial of Curcumin Effects on Cognition in Schizophrenia
Official title: A Pilot Trial of Curcumin Effects on Cognition in Schizophrenia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: schizophrenia
schizoaffective disorder
cognition
curcumin
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2015-06-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 are:

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.

Primary outcomes:
measure: Efficacy of curcumin (MATRICS - Composite Score t score)
timeFrame: 8 weeks
Secondary outcomes:
measure: Effect on psychiatric symptoms (PANSS - Positive Score)
timeFrame: 8 weeks
measure: Effect on psychiatric symptoms (PANSS- Negative Score)
timeFrame: 8 weeks
measure: Effect on psychiatric symptoms (PANSS- Total Score)
timeFrame: 8 weeks
measure: Efficacy of curcumin (MATRICS - Speed of Processing - t score)
timeFrame: 8 weeks
measure: Efficacy of curcumin (MATRICS - Attention/Vigilance t-score)
timeFrame: 8 weeks
measure: Efficacy of curcumin (MATRICS - Working Memory t-score)
timeFrame: 8 weeks
measure: Efficacy of curcumin (MATRICS - Verbal Learning t-score)
timeFrame: 8 weeks
measure: Efficacy of curcumin (MATRICS - Visual Learning t-score)
timeFrame: 8 weeks
measure: Efficacy of curcumin (MATRICS - Reasoning and Problem Solving t-score)
timeFrame: 8 weeks
measure: Efficacy of curcumin (MATRICS - Social Cognition t-score)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Connecticut Mental Health Center
state: Connecticut
Study officials:
affiliation: Yale Unversity School of Medicine
name: Cenk Tek, MD
role: PRINCIPAL_INVESTIGATOR
References: