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Targeting Circadian and Cognitive Dysfunction in Bipolar Disorder With Modafinil

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ClinicalTrials.gov Identifier: NCT01965925
Recruitment Status : Completed
First Posted : October 18, 2013
Last Update Posted : March 21, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Katherine Burdick, Icahn School of Medicine at Mount Sinai

Brief Summary:
This is an 8-week, randomized, placebo-controlled trial of modafinil in stable bipolar disorder patients. Results will provide information on a promising treatment for simultaneously treating both sleep and cognitive problems in stable bipolar patients. These disabling symptoms persist despite stable mood and are strongly associated with functional disability, making them important treatment targets that have not yet been adequately addressed.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Modafinil Drug: Placebo Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Targeting Circadian and Cognitive Dysfunction in Bipolar Disorder With Modafinil
Study Start Date : January 2014
Actual Primary Completion Date : November 9, 2017
Actual Study Completion Date : November 9, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Modafinil
Modafinil will be administered at baseline with a single dose of 100 mg/day QAM increased at week 1 to a single dose 200mg/day QAM. Patients will take drug upon waking with no adjustment in sleep schedule. Dosing will be flexible based on side effects with a maximum dose of 200 mg/day. Subjects will be discontinued if 100mg/day is not tolerated.
Drug: Modafinil
Ratio of 2:1 subjects will be in the experimental arm receiving modafinil for 8 weeks.
Placebo Comparator: Placebo
Subjects will take placebo upon waking once per day.
Drug: Placebo
For every randomly assigned 2 subjects receiving active drug, 1 will be randomly assigned to receive placebo for 8 weeks.



Primary Outcome Measures :
  1. safety of adjunctive modafinil [ Time Frame: up to 8 weeks ]
    Adverse events will be carefully measured and recorded in an effort to determine the base rates for common side effects in BD. Specifically, mood and psychosis ratings will be conducted.


Secondary Outcome Measures :
  1. MCCB [ Time Frame: baseline ]
    MATRICS Cognitive Consensus Batter to assess cognitive functioning

  2. MCCB [ Time Frame: week 4 ]
    MATRICS Cognitive Consensus Batter to assess cognitive functioning

  3. MCCB [ Time Frame: week 8 ]
    MATRICS Cognitive Consensus Batter to assess cognitive functioning

  4. sleep quality [ Time Frame: baseline ]
    To evaluate the effects of adjunctive modafinil in euthymic BD on measures of sleep quality and daytime wakefulness, using Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS)

  5. sleep quality [ Time Frame: week 4 ]
    To evaluate the effects of adjunctive modafinil in euthymic BD on measures of sleep quality and daytime wakefulness, using Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS)

  6. sleep quality [ Time Frame: week 8 ]
    To evaluate the effects of adjunctive modafinil in euthymic BD on measures of sleep quality and daytime wakefulness, using Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS)

  7. UPSA [ Time Frame: baseline ]
    UCSC Performance Skills Assessment assess functional ability

  8. UPSA [ Time Frame: week 4 ]
    UCSC Performance Skills Assessment assess functional ability

  9. UPSA [ Time Frame: week 8 ]
    UCSC Performance Skills Assessment assess functional ability

  10. QoL [ Time Frame: baseline ]
    Quality of Life Scale

  11. QoL [ Time Frame: week 4 ]
    Quality of Life Scale

  12. QoL [ Time Frame: week 8 ]
    Quality of Life Scale

  13. Vital signs [ Time Frame: up to 8 weeks ]
    vital signs including blood pressure

  14. Electrocardiogram [ Time Frame: baseline and week 8 ]
    comparison of electrocardiogram (EKG) results from week 8 to baseline.

  15. liver function tests [ Time Frame: baseline and week 8 ]
    comparison of liver function test results from week 8 to baseline

  16. chemistry panel [ Time Frame: baseline and week 8 ]
    comparison of chemistry panel results from week 8 to baseline

  17. Complete blood count [ Time Frame: baseline and week 8 ]
    comparison of complete blood count (CBC) results from week 8 to baseline

  18. urinalysis [ Time Frame: baseline and week 8 ]
    comparison of urinalysis results from week 8 to baseline

  19. Suicide risk scale [ Time Frame: up to 8 weeks ]
    Beck Scale for Suicidal Ideation and Columbia Suicide Severity Rating Scales

  20. Medication log [ Time Frame: up to 8 weeks ]
    Medication log for current medications and all medications administered



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DSM-IV Bipolar Disorder I or Bipolar Disorder II diagnosis
  • Affectively stable
  • Clinically acceptable, stably-dosed, mood stabilizing medication regimen for > 1 month prior to enrollment, with no medication changes planned over the 8-week study period.
  • Objective evidence of either a subjective sleep quality complaint and/or clinically-significant cognitive impairment at screening.

Exclusion Criteria:

  • History of Central Nervous System trauma, neurological disorder, ADHD, or a learning disability.
  • Positive urine toxicology or DSM-IV diagnosis of substance abuse/dependence within 3 months
  • Active, unstable medical problem that may interfere with sleep and/or cognition.
  • History of substance induced mania
  • Recent history of rapid cycling
  • Score of 2 or greater on the decreased need for sleep item on CARS-M
  • Any drug known to interfere with modafinil
  • More than 2 psychotropic medications
  • Abnormal lab or ECG result at screen
  • Significant suicidal ideation at baseline or at risk for suicidal behavior based on clinical judgment
  • participation in any other investigational cognitive enhancement study within 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01965925


Locations
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Katherine Burdick, PhD Icahn School of Medicine at Mount Sinai

Responsible Party: Katherine Burdick, Associate Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01965925     History of Changes
Other Study ID Numbers: GCO 12-1573
R34MH101267 ( U.S. NIH Grant/Contract )
First Posted: October 18, 2013    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018

Keywords provided by Katherine Burdick, Icahn School of Medicine at Mount Sinai:
Cognition
Sleep problems
Bipolar Disorder

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Cognitive Dysfunction
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Cognition Disorders
Neurocognitive Disorders
Modafinil
Armodafinil
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs