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Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder

Primary Purpose

Schizophrenia

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

modafinil

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Cognition, Obesity, Sedation

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

One arm

Arm Description

Study withdrawn due to lack of funds.

Outcomes

Primary Outcome Measures

Cognitive changes as measured by the NIH MATRICS - Consensus Cognitive Battery (MCCB)

Study withdrawn due to lack of funds.

Secondary Outcome Measures

Sedation and weight changes

Study withdrawn due to lack of funds.

Full Information

NCT ID

NCT00838227

First Posted

February 5, 2009

Last Updated

October 9, 2020

Sponsor

Manhattan Psychiatric Center

1. Study Identification

Unique Protocol Identification Number

NCT00838227

Brief Title

Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Withdrawn

Why Stopped

No source of funding to implement the study.

Study Start Date

February 2008 (undefined)

Primary Completion Date

January 2012 (Anticipated)

Study Completion Date

June 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Manhattan Psychiatric Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

Keywords

Schizophrenia, Cognition, Obesity, Sedation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

One arm

Arm Type

Experimental

Arm Description

Study withdrawn due to lack of funds.

Intervention Type

Drug

Intervention Name(s)

modafinil

Other Intervention Name(s)

Provigil

Intervention Description

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

Primary Outcome Measure Information:

Title

Cognitive changes as measured by the NIH MATRICS - Consensus Cognitive Battery (MCCB)

Description

Study withdrawn due to lack of funds.

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Sedation and weight changes

Description

Study withdrawn due to lack of funds.

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean-Pierre Lindenmayer, MD

Organizational Affiliation

Manhattan Psychiatric Center

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

19026265

Citation

Saavedra-Velez C, Yusim A, Anbarasan D, Lindenmayer JP. Modafinil as an adjunctive treatment of sedation, negative symptoms, and cognition in schizophrenia: a critical review. J Clin Psychiatry. 2009 Jan;70(1):104-12. doi: 10.4088/jcp.07r03982. Epub 2008 Nov 18.

Results Reference

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Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder

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