Bipolar Disorder Clinical Trial
Official title:
Targeting Circadian and Cognitive Dysfunction in Bipolar Disorder With Modafinil
Verified date | March 2018 |
Source | Icahn School of Medicine at Mount Sinai |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 18 |
Est. completion date | November 9, 2017 |
Est. primary completion date | November 9, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Icahn School of Medicine at Mount Sinai | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Icahn School of Medicine at Mount Sinai | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | safety of adjunctive modafinil | 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. | up to 8 weeks | |
Secondary | MCCB | MATRICS Cognitive Consensus Batter to assess cognitive functioning | baseline | |
Secondary | MCCB | MATRICS Cognitive Consensus Batter to assess cognitive functioning | week 4 | |
Secondary | MCCB | MATRICS Cognitive Consensus Batter to assess cognitive functioning | week 8 | |
Secondary | sleep quality | 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) | baseline | |
Secondary | sleep quality | 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) | week 4 | |
Secondary | sleep quality | 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) | week 8 | |
Secondary | UPSA | UCSC Performance Skills Assessment assess functional ability | baseline | |
Secondary | UPSA | UCSC Performance Skills Assessment assess functional ability | week 4 | |
Secondary | UPSA | UCSC Performance Skills Assessment assess functional ability | week 8 | |
Secondary | QoL | Quality of Life Scale | baseline | |
Secondary | QoL | Quality of Life Scale | week 4 | |
Secondary | QoL | Quality of Life Scale | week 8 | |
Secondary | Vital signs | vital signs including blood pressure | up to 8 weeks | |
Secondary | Electrocardiogram | comparison of electrocardiogram (EKG) results from week 8 to baseline. | baseline and week 8 | |
Secondary | liver function tests | comparison of liver function test results from week 8 to baseline | baseline and week 8 | |
Secondary | chemistry panel | comparison of chemistry panel results from week 8 to baseline | baseline and week 8 | |
Secondary | Complete blood count | comparison of complete blood count (CBC) results from week 8 to baseline | baseline and week 8 | |
Secondary | urinalysis | comparison of urinalysis results from week 8 to baseline | baseline and week 8 | |
Secondary | Suicide risk scale | Beck Scale for Suicidal Ideation and Columbia Suicide Severity Rating Scales | up to 8 weeks | |
Secondary | Medication log | Medication log for current medications and all medications administered | up to 8 weeks |
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