ClinicalTrials.gg
WithdrawnNCT00838227Updated Oct 14, 2020

Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder

A Phase 2 interventional study of modafinil in Schizophrenia, sponsored by Manhattan Psychiatric Center. Withdrawn. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2020-10-14.

Sponsored by Manhattan Psychiatric Center · Phase 2, Interventional, and Treatment

Why this study was withdrawn
No source of funding to implement the study.
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years to 64 Years
Sex
All
01

Study 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

Read the detailed description

This study was withdrawn due to no source of funding to implement the study.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

02

Conditions studied

  • Schizophrenia

Keywords

  • Schizophrenia
  • Cognition
  • Obesity
  • Sedation
03

In context

Schizophrenia

3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.

Browse Schizophrenia studies →

Lead sponsor

Manhattan Psychiatric Center is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • Capacity and willingness to give written .

Exclusion criteria

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)
  • or unstable cardiovascular, renal, hepatic, gastrointestinal, pulmonary or hematologic conditions;
  • 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram)

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Informed consent

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Clinically significant

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HIV

The human immunodeficiency virus, which weakens the immune system.

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05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    One arm

    Study withdrawn due to lack of funds.

    Drug: modafinil

Interventions

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

    Also known as: Provigil

06

What researchers measure

Primary outcomes

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

    Study withdrawn due to lack of funds.

    Time frame: 8 weeks

Secondary outcomes

  1. Sedation and weight changes

    Study withdrawn due to lack of funds.

    Time frame: 8 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 19026265 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2008, a primary completion of Jan 2012 and a completion of Jun 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 5, 2009
First posted
Feb 6, 2009
Start
Feb 2008
Primary completionEst.
Jan 2012
CompletionEst.
Jun 2012
Last update
Oct 14, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00838227
Lead sponsor
Manhattan Psychiatric Center
Responsible party
Jean-Pierre Lindenmayer (Study Principal Investigator, Manhattan Psychiatric Center) — Principal investigator
First posted
Feb 6, 2009
Start date
Feb 2008
Primary completion
Jan 2012 (estimated)
Completion
Jun 2012 (estimated)
Last update
Oct 14, 2020

Study contacts

Jean-Pierre Lindenmayer, MD
principal investigator · Manhattan Psychiatric Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Modafinil

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