Treating Sleep and Cognitive Problems in Bipolar Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Mount Sinai School of Medicine
Sponsor:
Information provided by (Responsible Party):
Katherine Burdick, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01965925
First received: October 16, 2013
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Bipolar Disorder
Drug: Modafinil
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Targeting Circadian and Cognitive Dysfunction in Bipolar Disorder With Modafinil

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • safety of adjunctive modafinil [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
    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.

  • safety of adjunctive modafinil [ Time Frame: week 4 ] [ Designated as safety issue: Yes ]
    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.

  • safety of adjunctive modafinil [ Time Frame: week 8 ] [ Designated as safety issue: Yes ]
    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:
  • MCCB [ Time Frame: baseline ] [ Designated as safety issue: No ]
    MATRICS Cognitive Consensus Batter to assess cognitive functioning

  • MCCB [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    MATRICS Cognitive Consensus Batter to assess cognitive functioning

  • MCCB [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    MATRICS Cognitive Consensus Batter to assess cognitive functioning

  • sleep quality [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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)

  • sleep quality [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    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)

  • sleep quality [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    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)

  • UPSA [ Time Frame: baseline ] [ Designated as safety issue: No ]
    UCSC Performance Skills Assessment assess functional ability

  • UPSA [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    UCSC Performance Skills Assessment assess functional ability

  • UPSA [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    UCSC Performance Skills Assessment assess functional ability

  • QoL [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Quality of Life Scale

  • QoL [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    Quality of Life Scale

  • QoL [ Time Frame: week 8 ] [ Designated as safety issue: No ]
    Quality of Life Scale

  • Vital signs [ Time Frame: up to 8 weeks ] [ Designated as safety issue: Yes ]
    vital signs including blood pressure

  • Electrocardiogram [ Time Frame: baseline and week 8 ] [ Designated as safety issue: Yes ]
    comparison of electrocardiogram (EKG) results from week 8 to baseline.

  • liver function tests [ Time Frame: baseline and week 8 ] [ Designated as safety issue: Yes ]
    comparison of liver function test results from week 8 to baseline

  • chemistry panel [ Time Frame: baseline and week 8 ] [ Designated as safety issue: Yes ]
    comparison of chemistry panel results from week 8 to baseline

  • Complete blood count [ Time Frame: baseline and week 8 ] [ Designated as safety issue: Yes ]
    comparison of complete blood count (CBC) results from week 8 to baseline

  • urinalysis [ Time Frame: baseline and week 8 ] [ Designated as safety issue: Yes ]
    comparison of urinalysis results from week 8 to baseline

  • Suicide risk scale [ Time Frame: up to 8 weeks ] [ Designated as safety issue: Yes ]
    Beck Scale for Suicidal Ideation and Columbia Suicide Severity Rating Scales

  • Medication log [ Time Frame: up to 8 weeks ] [ Designated as safety issue: Yes ]
    Medication log for current medications and all medications administered


Estimated Enrollment: 48
Study Start Date: January 2014
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01965925

Contacts
Contact: Carly Solon, BA 212-241-2751 carly.solon@mssm.edu
Contact: Meg Shanahan, MS 212-241-2494

Locations
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Carly Solon, BA    212-241-2751    carly.solon@mssm.edu   
Contact: Meg Shanahan, MS    212-659-9238      
Principal Investigator: Katherine Burdick, PhD         
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Katherine Burdick, PhD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Katherine Burdick, Associate Professor, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01965925     History of Changes
Other Study ID Numbers: GCO 12-1573, R34MH101267
Study First Received: October 16, 2013
Last Updated: February 5, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
Cognition
sleep problems
Bipolar Disorder

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on July 29, 2014