NCT00314314

Brief Summary

It is hypothesized that the intranasal administration of insulin will enhance hippocampal-dependent neurocognitive performance in euthymic patients with bipolar I or II disorder. This novel initiative represents a proof-of-concept study that insulin is salient to neurocognitive functioning and deficits in bipolar disorder and represents a novel and safe therapeutic avenue. The available literature suggests that the acute administration of intranasal insulin enhances cognition in memory impaired older adults with either Alzheimer's disease or minimal cognitive impairment. Prior research demonstrates a cognitive enhancing effect of insulin within one hour of the first intranasal insulin dose. Other studies suggest that the long-term administration of intranasal insulin (i.e. over eight weeks) in enhances memory performance in human volunteers. We aim to evaluate the acute and long-term effects of intranasal insulin administration in persons with bipolar disorder. As such we will be conducting the neuropsychological testing at three time points, the week before receiving insulin, within one hour of the first dose and after 8 weeks of insulin administration.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2006

Typical duration for phase_3

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 13, 2006

Completed
18 days until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

July 13, 2009

Status Verified

May 1, 2008

Enrollment Period

2.8 years

First QC Date

April 11, 2006

Last Update Submit

July 9, 2009

Conditions

Bipolar Disorder

Keywords

Bipolar Disorder, memory, executive functioning

Outcome Measures

Primary Outcomes (1)

  • Cognitive Tests: CVLT, Process Dissociation Tasks

    8 weeks

Secondary Outcomes (1)

  • Cognitive Tests: Trails A

    8 weeks

Study Arms (2)

1

EXPERIMENTAL
Drug: Intranasal Insulin

2

PLACEBO COMPARATOR
Drug: Diluent

Interventions

Intranasal InsulinDRUG

Intranasal spray; 40 IU qid; 8 weeks

1
DiluentDRUG

Intranasal spray; 8 weeks

2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Bipolar I Disorder - Euthymic
  • Bipolar II Disorder - Euthymic

You may not qualify if:

  • Unstable Medical Conditions
  • Currently Manic, Depressed or Mixed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Roger McIntyre, MD, FRCPC

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 11, 2006

First Posted

April 13, 2006

Study Start

May 1, 2006

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

July 13, 2009

Record last verified: 2008-05

Locations

CA(1)