SchizophreniaPhase 4InONCT00711464
Modafinil Effects on Cognition in Schizophrenia Patients
A Phase 4 study testing modafinil (M1, M2, M4) in people with Schizophrenia, run by University of California, Los Angeles at 2 sites in United States.
Trial summary
Patients with schizophrenia have problems in thinking, known as cognitive dysfunction. This includes many types of cognitive dysfunction, such as in attention, memory and language. Read more about this study
- Who is it for?
- Ages 18 to 54 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- modafinil (M1, M2, M4)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2008to Jul 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 54 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- adults age 18-54
- diagnosis of schizophrenia or schizoaffective disorder, or healthy with no personal or family history of mental illness
- able to provide informed consent
Who cannot join
- history of significant head injury or other neurological illness
- active psychiatric illness requiring significant acute care
- significant intellectual impairment (e.g. standardized full-scale IQ < 70)
- history of medical illness or treatment that is associated with significant increase in risk from modafinil treatment (e.g. cardiac disease)
- significant active substance abuse
- active pregnancy
- active treatment with medications that have drug interactions with modafinil
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California, Los Angeles
Los Angeles, California, 90024
University of California, Davis School of Medicine
Sacramento, California, 95817
About this study
Official title: A Dose-response Study of Modafinil Effects on Cognition in Schizophrenia Patients.
Patients with schizophrenia have problems in thinking, known as cognitive dysfunction. This includes many types of cognitive dysfunction, such as in attention, memory and language. These problems may explain why patients with schizophrenia think and act in unusual ways, and often have problems managing aspects of their lives that healthy adults take for granted. Unfortunately, the biochemical aspects of these dysfunctions are presently unknown, and it is not clear whether current psychiatric medications can improve these functions. A recent FDA-approved medication that may improve this function is modafinil. Studies in animals and healthy adults show that this medication can improve many of these cognitive functions. We plan to study the effects of modafinil on these cognitive processes, by giving various doses of this medication to patients before they perform tasks of these cognitive processes. We predict that when patients receive modafinil, they will perform better on a cognitive test, and that these benefits will depend on the dose given.
Read the detailed description
Schizophrenia is a disorder of cognition. The cognitive deficits of schizophrenia are present at the onset of the disorder, prior to medication exposure, are persistent during periods of remission, and are strongly related to functional outcome. These deficits prominently include prefrontal cortex-dependent functions. While existing medications effectively treat psychotic symptoms, they exhibit modest benefit at best for cognitive dysfunction. Studies of cognition in animal models indicate that the neurotransmitter systems that mediate many cognitive processes are not generally augmented by existing antipsychotic medications. Therefore, advances in the treatment of schizophrenia will require the study of agents with novel pharmacological profiles to establish their potential to remediate cognitive dysfunction.
This study will evaluate the effects of modafinil on the range of cognitive processes known to be disturbed in schizophrenia. Modafinil is an FDA-approved medication with a unique pharmacological profile and an increasing range of off-label indications. Its neurochemical effects in animal models include elevation of extracellular dopamine (DA), noradrenaline (NA) and glutamate in the neocortex. This profile is favorable for the enhancement of cognitive processes. These neurochemical effects also appear to be selective for cortical versus subcortical brain regions, suggesting that modafinil may have minimal effects on psychotic symptoms, or extrapyramidal, autonomic and hormonal side effects. In addition, it differs from amphetamine in structure, neurochemical profile and behavioral effects, with a lower risk of addictive or cerebrovascular effects. Recent studies in animal models, healthy adults and adults with psychiatric and neurological disorders indicate that modafinil improves prefrontal cognitive functions. This suggests that modafinil is a leading candidate for the treatment of cognitive dysfunction in schizophrenia. We aim to test modafinil effects on the remediation of deficits in cognition in individuals with schizophrenia. We will vary the dose within each participant to evaluate dose-response relationships, and directly compare cognition outcome measures for sensitivity to drug effects.
- Conditions
- Schizophrenia
- Being tested
- modafinil (M1, M2, M4)
- Keywords
- cognition, pharmacology, memory, attention
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modafinil (M1, M2, M4)Drug
Also called Provigil
modafinil 100, 200, and 400 mg oral dose
| Study group | Role | What they receive |
|---|---|---|
| 100 mg | Experimental | modafinil 100 milligrams oral dose Receives: Drug: modafinil (M1, M2, M4) |
| 200 mg | Experimental | modafinil 200 mg oral dose Receives: Drug: modafinil (M1, M2, M4) |
| 400 mg | Experimental | modafinil 400 mg oral dose Receives: Drug: modafinil (M1, M2, M4) |
| Placebo | Placebo comparator | Single oral placebo capsule Receives: Drug: modafinil (M1, M2, M4) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Performance
Percent Accuracy on high-control (i.e. difficult) condition on test of cognitive control
Measured: 3-5 hours
Secondary outcomes (2)
Systolic Blood Pressure
systolic blood pressure in mm Hg
Measured: 3-5 hours
Heart Rate
beats per minute
Measured: 3-5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2008 (estimated)
- Study startMay 2008
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Minzenberg, MD, University of California, Davis
- Investigators
- Michael J. Minzenberg, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00711464
- Sponsor's protocol ID
- 200715868-1
- Acronym
- InO
- Status last verified
- Aug 2017
- First submitted
- 2 Jul 2008
- Last updated
- 29 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-response Study of Modafinil Effects on Cognition in Schizophrenia Patients.
- ClinicalTrials.gov ID
- NCT00711464
- Acronym / sponsor ID
- InO / 200715868-1
- Conditions
- Schizophrenia
- Keywords
- cognition, pharmacology, memory, attention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 8 Jul 2008 (estimated)
- Results
- Posted 29 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with schizophrenia have problems in thinking, known as cognitive dysfunction. This includes many types of cognitive dysfunction, such as in attention, memory and language. These problems may explain why patients with schizophrenia think and act in unusual ways, and often have problems managing aspects of their lives that healthy adults take for granted. Unfortunately, the biochemical aspects of these dysfunctions are presently unknown, and it is not clear whether current psychiatric medications can improve these functions. A recent FDA-approved medication that may improve this function is modafinil. Studies in animals and healthy adults show that this medication can improve many of these cognitive functions. We plan to study the effects of modafinil on these cognitive processes, by giving various doses of this medication to patients before they perform tasks of these cognitive processes. We predict that when patients receive modafinil, they will perform better on a cognitive test, and that these benefits will depend on the dose given.
Detailed description
Schizophrenia is a disorder of cognition. The cognitive deficits of schizophrenia are present at the onset of the disorder, prior to medication exposure, are persistent during periods of remission, and are strongly related to functional outcome. These deficits prominently include prefrontal cortex-dependent functions. While existing medications effectively treat psychotic symptoms, they exhibit modest benefit at best for cognitive dysfunction. Studies of cognition in animal models indicate that the neurotransmitter systems that mediate many cognitive processes are not generally augmented by existing antipsychotic medications. Therefore, advances in the treatment of schizophrenia will require the study of agents with novel pharmacological profiles to establish their potential to remediate cognitive dysfunction.
This study will evaluate the effects of modafinil on the range of cognitive processes known to be disturbed in schizophrenia. Modafinil is an FDA-approved medication with a unique pharmacological profile and an increasing range of off-label indications. Its neurochemical effects in animal models include elevation of extracellular dopamine (DA), noradrenaline (NA) and glutamate in the neocortex. This profile is favorable for the enhancement of cognitive processes. These neurochemical effects also appear to be selective for cortical versus subcortical brain regions, suggesting that modafinil may have minimal effects on psychotic symptoms, or extrapyramidal, autonomic and hormonal side effects. In addition, it differs from amphetamine in structure, neurochemical profile and behavioral effects, with a lower risk of addictive or cerebrovascular effects. Recent studies in animal models, healthy adults and adults with psychiatric and neurological disorders indicate that modafinil improves prefrontal cognitive functions. This suggests that modafinil is a leading candidate for the treatment of cognitive dysfunction in schizophrenia. We aim to test modafinil effects on the remediation of deficits in cognition in individuals with schizophrenia. We will vary the dose within each participant to evaluate dose-response relationships, and directly compare cognition outcome measures for sensitivity to drug effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 100 mg | Experimental | Drug: modafinil (M1, M2, M4)modafinil 100 milligrams oral dose |
| 200 mg | Experimental | Drug: modafinil (M1, M2, M4)modafinil 200 mg oral dose |
| 400 mg | Experimental | Drug: modafinil (M1, M2, M4)modafinil 400 mg oral dose |
| Placebo | Placebo comparator | Drug: modafinil (M1, M2, M4)Single oral placebo capsule |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- adults age 18-54
- diagnosis of schizophrenia or schizoaffective disorder, or healthy with no personal or family history of mental illness
- able to provide informed consent
Key exclusion criteria (7 listed)
- history of significant head injury or other neurological illness
- active psychiatric illness requiring significant acute care
- significant intellectual impairment (e.g. standardized full-scale IQ < 70)
- history of medical illness or treatment that is associated with significant increase in risk from modafinil treatment (e.g. cardiac disease)
- significant active substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| modafinil (M1, M2, M4)Also: Provigilmodafinil 100, 200, and 400 mg oral dose | Drug | 100 mg, 200 mg, 400 mg, Placebo |
Primary outcome
Cognitive Performance
Time frame: 3-5 hours
Percent Accuracy on high-control (i.e. difficult) condition on test of cognitive control
2 secondary outcomes
Systolic Blood Pressure
Time frame: 3-5 hours
Heart Rate
Time frame: 3-5 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J. Minzenberg, MD principal investigator
University of California, Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing modafinil (M1, M2, M4) in people with Schizophrenia, run by University of California, Los Angeles at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Performance (time frame: 3-5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2017.