NCT01965925

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2017

Completed
Last Updated

March 21, 2018

Status Verified

March 1, 2018

Enrollment Period

3.9 years

First QC Date

October 16, 2013

Last Update Submit

March 20, 2018

Conditions

Bipolar Disorder

Keywords

CognitionSleep problemsBipolar Disorder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (20)

  • MCCB

    baseline

  • MCCB

    week 4

  • MCCB

    week 8

  • sleep quality

    baseline

  • sleep quality

    week 4

  • +15 more secondary outcomes

Study Arms (2)

Modafinil

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Subjects will take placebo upon waking once per day.

Drug: Placebo

Interventions

ModafinilDRUG

Ratio of 2:1 subjects will be in the experimental arm receiving modafinil for 8 weeks.

Modafinil
PlaceboDRUG

For every randomly assigned 2 subjects receiving active drug, 1 will be randomly assigned to receive placebo for 8 weeks.

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

  • Lipschitz JM, Perez-Rodriguez M, Majd M, Larsen E, Locascio J, Pike CK, Shanahan M, Burdick KE. Modafinil's effects on cognition and sleep quality in affectively-stable patients with bipolar disorder: a pilot study. Front Psychiatry. 2023 Sep 4;14:1246149. doi: 10.3389/fpsyt.2023.1246149. eCollection 2023.

    PMID: 37732080DERIVED

MeSH Terms

Conditions

Bipolar DisorderParasomnias

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Benzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Katherine Burdick, PhD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 16, 2013

First Posted

October 18, 2013

Study Start

January 1, 2014

Primary Completion

November 9, 2017

Study Completion

November 9, 2017

Last Updated

March 21, 2018

Record last verified: 2018-03

Locations

US(1)