NCT01242371

Brief Summary

The investigators intend to explore the hypothesis that symptoms of schizophrenia may be reduced by the administration of a probiotic supplement when used in addition to standard antipsychotic medications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

August 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 17, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

November 14, 2013

Completed
Last Updated

February 5, 2019

Status Verified

January 1, 2019

Enrollment Period

2 years

First QC Date

November 16, 2010

Results QC Date

August 29, 2013

Last Update Submit

January 17, 2019

Conditions

SchizophreniaSchizoaffective Disorder

Keywords

SchizophreniaSchizoaffectiveProbiotic supplementsGliadinCasein

Outcome Measures

Primary Outcomes (1)

  • Change in Positive and Negative Syndrome Scale (PANSS) Score From the Start to the End of the Double-blind Treatment Phase (Week 0 to Week 14)

    The Positive and Negative Syndrome Scale (PANSS) measures psychiatric symptomatology, especially related to psychosis. The complete PANSS contains ratings for 30 symptoms, including 7 positive symptoms, 7 negative symptoms, and 16 general psychiatric symptoms. The severity of each symptom is rated on a scale ranging from 1 (minimal) to 7 (extreme); higher scores indicate increased symptomatology. Total PANSS scores include scores from all categories and range from 30 to 210 units on a scale.

    14 weeks (week 0 to week 14)

Secondary Outcomes (2)

  • Gastrointestinal Functioning From the Beginning to the End of the Double-blind Treatment Phase Weeks 0-14

    14 weeks (weeks 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 & 14)

  • Measurement of Gliadin and Casein Antibody Levels

    16 weeks (baseline prior to placebo run in to week 14)

Study Arms (2)

Probiotic Supplement

ACTIVE COMPARATOR

Probiotic supplement 1 tablet by mouth daily for 14 weeks after 2 week placebo run-in

Dietary Supplement: Probiotic Supplement

Identical-appearing Placebo

PLACEBO COMPARATOR

Identical appearing placebo 1 tablet by mouth daily for 14 weeks after 2 week placebo run-in

Dietary Supplement: Identical-appearing Placebo

Interventions

Probiotic SupplementDIETARY_SUPPLEMENT

Probiotic Supplement 1 tablet by mouth daily

Probiotic Supplement
Identical-appearing PlaceboDIETARY_SUPPLEMENT

Probiotic identical placebo 1 tablet by mouth daily

Identical-appearing Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65.
  • Capacity for written informed consent.
  • Primary Axis I diagnosis (DSM-IV) of schizophrenia, any type, OR schizoaffective disorder (APA, 1994).
  • Currently an outpatient at the time of enrollment.
  • Residual psychotic symptoms which are at least moderately severe as evidenced by one or more PANSS positive symptom scores, and/or PANSS negative symptom scores of 4 or more; OR a total PANSS score of 50 or more, containing at least three positive or negative items with scores of 3 or more at screening.
  • Conformance to PORT Treatment Recommendation re Maintenance Antipsychotic Medication Dose (Buchanan et al., 2010).
  • Receiving antipsychotic medication for at least 8 weeks prior to starting the study with no medication changes within the previous 21 days.
  • Proficient in the English language.

You may not qualify if:

  • Diagnosis of mental retardation.
  • Any clinically significant or unstable medical disorder as determined by the investigators, including congestive heart failure, abnormal liver function or disease, renal failure, acute pancreatitis, any diagnosis of cancer undergoing active treatment, HIV infection or other immunodeficiency condition.
  • History of IV drug use.
  • Primary diagnosis of substance abuse or dependence according to DSM-IV criteria within the last three months.
  • Participated in any investigational drug trial in the past 30 days.
  • Pregnant or planning to become pregnant during the study period.
  • Receipt of antibiotic medication within the previous 14 days (as anaerobic organisms residing in the gastrointestinal tract may be minimally affected by antibiotics).
  • Documented celiac disease (as such persons should be on a gluten-free diet as this is the standard care).
  • Of note, the investigators are not limiting the study to individuals with elevated levels of gliadin or casein antibodies as the investigators intend to look at these levels as a predictor of response.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheppart Pratt Health System

Towson, Maryland, 21204, United States

Location

Related Publications (1)

  • Dickerson FB, Stallings C, Origoni A, Katsafanas E, Savage CL, Schweinfurth LA, Goga J, Khushalani S, Yolken RH. Effect of probiotic supplementation on schizophrenia symptoms and association with gastrointestinal functioning: a randomized, placebo-controlled trial. Prim Care Companion CNS Disord. 2014;16(1):PCC.13m01579. doi: 10.4088/PCC.13m01579. Epub 2014 Feb 13.

    PMID: 24940526DERIVED

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Limitations and Caveats

Did not perform more detailed measures of gastrointestinal functioning or obtain a more complete history of participants' gastrointestinal symptoms and associated treatment

Results Point of Contact

Title
Dr. Faith Dickerson
Organization
Sheppard Pratt
fdickerson@sheppardpratt.org
410-938-4359

Study Officials

  • Faith B Dickerson, PhD, MPH

    Sheppard Pratt Health System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Stanley Research Program

Study Record Dates

First Submitted

November 16, 2010

First Posted

November 17, 2010

Study Start

August 1, 2010

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

February 5, 2019

Results First Posted

November 14, 2013

Record last verified: 2019-01

Locations

US(1)