Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder

Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder: A Pilot Study

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00838227

Enrollment

Registered

2009-02-06

Start date

2008-02-29

Completion date

2012-06-30

Last updated

2020-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Schizophrenia, Cognition, Obesity, Sedation

Brief summary

This is an open label 8-week trial of modafinil up to 400 mg daily added to a stable antipsychotic regimen to evaluate the effect modafinil on cognition, sedation, and weight in patients with chronic schizophrenia. We hypothesize that modafinil, a wake-promoting agent, will lead to improved cognition, increased wakefulness, and decreased weight in patients with schizophrenia who are on stable antipsychotic regimens

Detailed description

This study was withdrawn due to no source of funding to implement the study. No participants were enrolled for this study.

Interventions

DRUGmodafinil

Modafinil up to 400 mg daily will be added to a stable antipsychotic regimen

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Inclusion criteria

* Diagnostic and Statistical Manual-IV diagnosis of schizophrenia (all subtypes), illness duration greater than three years * Auditory and visual acuity adequate to complete cognitive tests * Stable dose of antipsychotics for at least 2 weeks prior to entry * Good physical health determined by complete physical examination, laboratory tests, and EKG * Capacity and willingness to give written informed consent.

Exclusion criteria

* Inability to read or speak English * Documented disease of the central nervous system * History of intellectual impairment pre-dating onset of symptoms of psychosis (e.g. mental retardation) * Clinically significant or unstable cardiovascular, renal, hepatic, gastrointestinal, pulmonary or hematologic conditions; * HIV positive * Patients on antidepressants, including monoamine oxidase inhibitors * Uncontrolled hypertension * Pregnancy * Patients with a current diagnosis of substance dependence * Significant history of violence * History of an eating disorder * Ready for discharge within the following 8 weeks.

Design outcomes

Primary

Measure	Time frame	Description
Cognitive changes as measured by the NIH MATRICS - Consensus Cognitive Battery (MCCB)	8 weeks	Study withdrawn due to lack of funds.

Secondary

Measure	Time frame	Description
Sedation and weight changes	8 weeks	Study withdrawn due to lack of funds.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026