NCT00573417

Brief Summary

This pilot study is an eight-week, randomized, double-blind, placebo-controlled, escalating dose trial of the novel vigilance-promoting drug, modafinil, added to a stable dose of clozapine in 40 patients with schizophrenia or schizoaffective disorder. Modafinil will be initiated at 100 mg/d. After 2 weeks, the study drug may be increased to 200 mg/d and after 4 weeks, study drug may be increased to a maximum of 300 mg/d. Dose escalation will be based upon persistence of sedation versus emergence of side effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4 schizophrenia

Timeline
Completed

Started Sep 2003

Longer than P75 for phase_4 schizophrenia

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

September 1, 2003

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 14, 2007

Completed
Last Updated

August 12, 2009

Status Verified

August 1, 2009

Enrollment Period

4.2 years

First QC Date

December 13, 2007

Last Update Submit

August 11, 2009

Conditions

Schizophrenia

Keywords

SchizophreniaClozapineCognitionMetabolic SyndromeNegative SymptomsWakefulnessFatigue

Outcome Measures

Primary Outcomes (1)

  • Evaluate the effect size of modafinil compared to placebo upon cognitive functioning using a standard battery of cognitive tests.

    8 weeks

Secondary Outcomes (5)

  • Evaluate tolerability and safety of modafinil compared to placebo using the SAFTEE and vital signs.

    8 weeks

  • Evaluate the effect size of modafinil compared to placebo upon wakefulness and fatigue using the Epworth Sleepiness Scale (ESS) and the Fatigue Severity Scale (FSS).

    8 weeks

  • Evaluate the effect size of modafinil compared to placebo upon negative symptoms using the SANS total score.

    8 Weeks

  • Evaluate the effect size of modafinil compared to placebo upon weight, BMI, waist/hip circumference and fasting glucose and lipids.

    8 weeks

  • Effect the variability of response in placebo and modafinil groups for each of the outcome measures.

    8 weeks

Study Arms (2)

modafinil

EXPERIMENTAL

modafinil 100mg, 200mg, or 300mg (dose escalation)

Drug: modafinil

placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

modafinilDRUG

modafinil 100mg tablets. dose excalation up to 300mg

Also known as: Provigil
modafinil
PlaceboDRUG
placebo

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of Schizophrenia, any subtype or schizoaffective disorder
  • Ages 18-65 years
  • Capable of providing informed consent, or capable of providing assent with a guardian who provides informed consent
  • Stable dose of clozapine for at least 1 month
  • Three months of stable psychotic symptoms

You may not qualify if:

  • Serious medical or neurological illness (unstable cardiac disease, seizure disorder, malignancy, liver or renal impairment, etc.)
  • Current substance abuse
  • Pregnancy, nursing, or unwilling to use appropriate birth control measures during participation if female and fertile.
  • Unable to complete neuropsychological tests
  • History of serious blood dyscrasia requiring discontinuation of clozapine
  • Serious suicidal or homicidal risk within the past six months
  • Current treatment with a psychostimulant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Freedom Trail Clinic

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • Freudenreich O, Henderson DC, Macklin EA, Evins AE, Fan X, Cather C, Walsh JP, Goff DC. Modafinil for clozapine-treated schizophrenia patients: a double-blind, placebo-controlled pilot trial. J Clin Psychiatry. 2009 Dec;70(12):1674-80. doi: 10.4088/JCP.08m04683. Epub 2009 Aug 11.

    PMID: 19689921DERIVED

MeSH Terms

Conditions

SchizophreniaMetabolic SyndromeFatigue

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Donald Goff, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 13, 2007

First Posted

December 14, 2007

Study Start

September 1, 2003

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

August 12, 2009

Record last verified: 2009-08

Locations

US(1)