Treatment of Refractory Schizophrenia With Riluzole

NCT00375050 | Completed

• 1 other identifier: 13175
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study would evaluate the benefits of riluzole add-on treatment to patients with schizophrenia who are already receiving medications, but still experience symptoms. Neuroprotective medication riluzole is currently approved for treatment of amyotrophic lateral sclerosis (Lou Gehrig's disease), a severe neurological illness. Due to its unique mechanism of action, riluzole, if effective in helping the symptoms of schizophrenia, would open novel directions in treatment of schizophrenia.

Conditions

Schizophrenia; Schizoaffective

Outcome Measures

Primary Outcomes (12)

• PANSS (Positive and Negative Syndrome Scale)

  12 weeks

• SANS (Scale for the Assessment of Negative Symptoms)

  12 weeks

• CGI- Clinical Global Impression Scale

  12 weeks

• Calgary Depression Scale: To assess mood symptoms in psychotic patients

  12 weeks

• Neuropsychological tests:

  12 weeks

• Computerized Working Memory Task

  12 weeks

• Verbal Fluency

  12 weeks

• HVLT-Hopkins Verbal Learning Test

  12 weeks

• DSST-Digit Symbol Substitution Test

  12 weeks

• Continuous performance test

  12 weeks

• CANTAB- Cambridge Neuropsychological Test Automated Battery

  12 weeks

• AIMS (abnormal involuntary movement scale), EPS (extrapyramidal symptom) assessment, Barnes akathisia scale, Simpson Angus scale

  12 weeks

Study Arms (2)

Riluzole

EXPERIMENTAL

Drug: Riluzole

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Riluzole DRUG

Also known as: Rilutek

Riluzole

Placebo DRUG

placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women with a diagnosis of schizophrenia or schizoaffective disorder as defined by DSM- IV criteria.
• Age between 18 and 65. Special attention will be placed on selective enrolling of patients 18-25 to assess that they have been exposed to adequate medication trials (minimum two medications) for sufficient length of time.
• During the 3 months prior to study entry, the patient must not have been an inpatient in a hospital for longer than 4 weeks (cumulative hospitalizations) due to worsening of psychiatric illness (although could have been participating in an inpatient research protocol).
• Patients able to comprehend and satisfactorily comply with the protocol requirements;
• Patients with a PANSS total score of 60 or higher and a score of 4 (moderate) or higher on two or more of the following PANSS items: delusions, hallucinatory behavior, conceptual disorganization or suspiciousness.
• CGI scale rating of at least mildly ill, but not greater than severely ill.
• For women only: The patient must be non-pregnant, non-lactating, or has undergone tubal ligation, bilateral oophorectomy or hysterectomy; or the patient must be at least one year post menopausal; or the patient a) has negative urine or serum pregnancy test (Beta HCG) and b) agrees to reliably practice contraception throughout the study.

You may not qualify if:

• Primary psychiatric diagnosis other than schizophrenia or schizoaffective disorder.
• Patients who have had psychosurgery
• Recent (\< 3 weeks) change in antipsychotic regimen
• Presence of clinically significant somatic disease that requires frequent changes in medications or that could be aggravated by taking riluzole (i.e. severe liver illness)
• Currently receiving treatment with potentially hepatotoxic drugs (e.g. allopurinol, methyldopa, sulfasalazine)
• HIV positive, as assessed by blood testing (in part to avoid subjects with possible brain HIV infection and to avoid rare complications of rarely occurring riluzole induced neutropenia)
• Patients who pose immediate or significant enough risk for suicide or harm for others as assessed by the study MD.
• Pregnant or nursing women, or women of childbearing potential who do not use adequate contraception or who are judged to be unreliable in their use of contraception (because there is not enough experience with riluzole use in nursing or pregnant women)

Sponsors & Collaborators

• Yale University: lead
• Stanley Medical Research Institute: collaborator

Study Sites (1)

Yale Department of Psychiatry

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Riluzole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Benzothiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Zoran Zimolo, MD, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2006
• First Posted: September 12, 2006
• Study Start: May 1, 2002
• Primary Completion: August 29, 2006
• Study Completion: August 29, 2006
• Last Updated: December 9, 2019

Record last verified: 2019-12

Locations

US (1)