NCT01320982

Brief Summary

The objective of the study is to evaluate the efficacy of Pramipexole, Minocycline and Aspirin compared to placebo, as add-on to anti-psychotics in the treatment of patients with schizophrenia.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P50-P75 for phase_3 schizophrenia

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_3 schizophrenia

Geographic Reach
2 countries

14 active sites

Status
unknown

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

February 2, 2011

Completed
27 days until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 23, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

March 23, 2011

Status Verified

March 1, 2011

Enrollment Period

1.3 years

First QC Date

February 2, 2011

Last Update Submit

March 22, 2011

Conditions

SchizophreniaSchizoaffective Disorder

Keywords

Schizophreniaschizoaffective disorder

Outcome Measures

Primary Outcomes (2)

  • Positive and Negative Syndrome Scale (PANSS)total score

    Change from baseline in Positive and Negative Syndrome Scale (PANSS)total score at 8 weeks

    Positive and Negative Syndrome Scale (PANSS) total score at week 8

  • Positive and Negative Syndrome Scale (PANSS)total score

    Change from baseline in Positive and Negative Syndrome Scale (PANSS)total score at 16 weeks.

    Positive and Negative Syndrome Scale (PANSS) total score at week 16

Secondary Outcomes (24)

  • Positive and Negative Syndrome Scale (PANSS)

    Positive and Negative Syndrome Scale (PANSS)positive sub-scale score at week 2

  • Positive and Negative Syndrome Scale (PANSS)

    Positive and Negative Syndrome Scale(PANSS) positive sub-scale score at week 4 .

  • Positive and Negative Syndrome Scale (PANSS)

    Positive and negative syndrome scale(PANSS) positive sub-scale score at week 8.

  • Positive and Negative Syndrome Scale (PANSS)

    Positive and negative syndrome scale(PANSS) positive sub-scale score at week 16.

  • Positive and Negative Syndrome Scale (PANSS)

    Positive and Negative Syndrome Scale (PANSS) negative sub-scale score at week 2

  • +19 more secondary outcomes

Study Arms (4)

minocycline

ACTIVE COMPARATOR

minocycline

Drug: minocycline

pramipexole

ACTIVE COMPARATOR

pramipexole

Drug: pramipexole

acetylsalicylic acid

ACTIVE COMPARATOR

acetylsalicylic acid

Drug: acetylsalicylic acid

Placebo

PLACEBO COMPARATOR

Placebo

Drug: placebo

Interventions

minocyclineDRUG

minocycline 100 mg/bid

minocycline
pramipexoleDRUG

pramipexole 0.125, 0.25, 0.5 and 0.75 mg/bid

pramipexole
acetylsalicylic acidDRUG

acetylsalicylic acid 500mg/ bid

acetylsalicylic acid
placeboDRUG

placebo bid

Placebo

Eligibility Criteria

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

You may qualify if:

  • Male or female, 18-65 years of age, inclusive
  • Females who are abstinent or practicing an established method of birth control (oral contraceptive tablets, hormonal implant device, hormone patch, injectable contraceptive, intrauterine device.
  • Willing and able to provide informed consent, after the nature of the study has been fully explained
  • Current DSM-IV-TR diagnosis of schizophrenia or schizoaffective disorder as confirmed by modified Structured Clinical Interview for DSM Disorders (SCID) and having had at least 2 prior schizophrenic episodes, or continually ill for at least 6 months.
  • Symptoms: 4 (moderate) or above on Clinical Global Impression scale (CGI-S)and 4 (moderate)or above score on two of the following four Positive and negative syndrome scale (PANSS) items: delusions, hallucinatory behaviors, conceptual disorganization or suspiciousness/ persecution, and/or a total PANSS negative symptoms score of 18.
  • Must be on any antipsychotic drug, for at least 2 weeks prior to the baseline visit, at doses within the Patient Outcome Research Team (PORT) criteria, whenever possible. Patients receiving higher doses will have their records reviewed to insure that their dose is required and, if possible, will be stabilized on a lower dose prior to study entry.
  • Inpatients or outpatients. Inpatients will be randomized 3 days or more after admission

You may not qualify if:

  • Unwilling or unable, in the opinion of the Investigator, to comply with study instructions
  • Pregnant or breast-feeding
  • Unstable medical disease (malignancy, poorly controlled diabetes, active ischemic cardiac disease, or cardiomyopathy, serious pulmonary disease, kidney disease, impaired liver functioning. History of hemorrhagic CVA or peptic ulcer disease.
  • Patients treated with: any of the trial medications i.e. pramipexole/minocycline/ acetylsalicylic acid, NSAIDs, anti-coagulants, sucralfate, cimetidine, amantadine, mexiletine.
  • Likely allergy or sensitivity to raloxifene/pramipexole/minocycline/acetylsalicylic acid.
  • At significant risk of committing suicide, or in the opinion of the Investigator, currently is at imminent risk of suicide or harming others.
  • Patients with a current DSM-IV substance or alcohol abuse. Patients with a history of and/or current recreational use of cannabinoids or alcohol, and/or patients who smoke cigarettes can be included.
  • Concurrent delirium, mental retardation, drug-induced psychosis, or history of clinically significant brain trauma documented by CT or MRI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Clinica de Psihiatrie

Arad, Romania

Location

Spitalul de Psihiatrie Botosani, Sectia Psihiatrie

Botoșani, Romania

Location

Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"

Bucharest, Romania

Location

Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"

Bucharest, Romania

Location

Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"

Bucharest, Romania

Location

Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"

Bucharest, Romania

Location

Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"

Bucharest, Romania

Location

Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"

Bucharest, Romania

Location

Spitalul Clinic de Psihiatrie "Prof. Dr. Alex. Obregia"

Bucharest, Romania

Location

Sp. Jud. "Prof. Dr.O. Fodor"

Cluj-Napoca, Romania

Location

Spitalul Clinic Judetean de Urgenta Cluj

Cluj-Napoca, Romania

Location

Spitalul Clinic de Psihiatrie Socola, Iasi

Iași, Romania

Location

Spitalul Clinic de Psihiatrie Socola, Iasi

Iași, Romania

Location

Related Publications (2)

  • Levi L, Zamora D, Nastas I, Gonen I, Radu P, Matei V, Ciobanu AM, Nacu A, Boronin L, Karakrah L, Davidson M, Davis JM, Weiser M. Add-On Pramipexole for the Treatment of Schizophrenia and Schizoaffective Disorder: A Randomized Controlled Trial. J Clin Psychiatry. 2022 Aug 1;83(5):21m14233. doi: 10.4088/JCP.21m14233.

    PMID: 35921506DERIVED

  • Weiser M, Zamora D, Levi L, Nastas I, Gonen I, Radu P, Matei V, Nacu A, Boronin L, Davidson M, Davis JM. Adjunctive Aspirin vs Placebo in Patients With Schizophrenia: Results of Two Randomized Controlled Trials. Schizophr Bull. 2021 Jul 8;47(4):1077-1087. doi: 10.1093/schbul/sbaa198.

    PMID: 33479775DERIVED

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

MinocyclinePramipexoleAspirin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsBenzothiazolesThiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingSalicylatesHydroxybenzoatesPhenolsBenzene Derivatives

Study Officials

  • Mark Weiser, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Weiser, MD

CONTACT

972-52-6666575mweiser@netvision.net.il

Katya Rubinstein, MA

CONTACT

972-3-5303454rubins.katya@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

February 2, 2011

First Posted

March 23, 2011

Study Start

March 1, 2011

Primary Completion

June 1, 2012

Study Completion

July 1, 2012

Last Updated

March 23, 2011

Record last verified: 2011-03

Locations

RO(13)IL(1)