Bipolar DisorderPhase 3NCT00314314
The Effect of Intranasal Insulin on Neurocognitive Function in Euthymic Patients With Bipolar Disorder
A Phase 3 study testing Intranasal Insulin and Diluent in people with Bipolar Disorder, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Intranasal Insulin and Diluent
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- May 2006to Mar 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Bipolar I Disorder - Euthymic
- Bipolar II Disorder - Euthymic
Who cannot join
- Unstable Medical Conditions
- Currently Manic, Depressed or Mixed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind Controlled Trial Evaluating the Effect of Intranasal Insulin on Neurocognitive Function in Euthymic Patients With Bipolar Disorder
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.
Read the detailed description
Sixty verified euthymic individuals (age 18-60) with DSM-IV-TR defined Bipolar Disorder (diagnosis will be confirmed by the Mini International Neuropsychiatric Interview for the DSM-IV) will be enrolled. Individuals below the age of 18 and over 60 are excluded as they are not seen at the recruiting center. Enrollment into the study is voluntary. Eligible subjects will provide written informed consent. Subjects will be enrolled from the outpatient Mood Disorders Psychopharmacology Unit (MDPU), University health Network, University of Toronto. Study information and consent procedures will be provided by personnel other than the primary treatment provider.
Euthymia (the absence of clinically meaningful symptoms) will be prospectively defined as a score of 3 or less with the Hamilton Rating Scale for Depression 7 item (HAMD-7) and a score of 7 or less on the Young Mania Rating Scale (YMRS) at initial assessment and at 1 month (baseline). The HAMD-7 and YMRS will be repeated at every follow-up visit.
Conventional pharmacological treatments for bipolar disorder will be permitted (e.g. Lithium, anticonvulsant mood stabilizers, antipsychotics, antidepressants, anxiolytics/hypnotics, etc.). Medication regimens will remain stable throughout the duration of the study. Enrollment into the study is voluntary. Eligible subjects will provide written informed consent. Study information and consent procedures will be provided by personnel other than the primary treatment provider. Subjects will be enrolled from the outpatient Mood Disorders Psychopharmacology Unit, University Health Network, University of Toronto. Illness characteristics will be obtained from the patient interview and hospital medical records.
Subjects will be compensated for sundry expenses (i.e. parking, public transport). Subjects will not receive financial compensation for being a participant in the study. The ongoing provision of care is not contingent on enrollment and/or completion of the study protocol.
Subjects will be excluded if they are receiving corticosteroids or antihypertensive medications; another current Axis I psychiatric disorder; a neurological or medically unstable condition; substance or alcohol misuse in the past 3 months; or electroconvulsive therapy in the last year. Other exclusion criteria include the presence of diabetes mellitus or hyperglycemia, BMI equal or greater than 40 kg/m^2 or inability to provide written informed consent. Patients who are actively suicidal or evaluated as being a suicide risk will be excluded. Other reasons for discontinuation are voluntary discontinuation, failure to complete 1 month of euthymia, impaired fasting glucose (i.e. 6.1-6.9 mmol/L), non-compliance (i.e. failure to administer > 80% of the assigned treatment in any week). Insulin will be measured quantitatively on a weekly basis; subjects will also complete a diary of when they took intranasal insulin and their prescribed medication.
The ongoing provision of care is not contingent on enrollment and/or completion of the study protocol. Furthermore, there will be ongoing communication with the subject's primary care provider in regards to their participation in this study.
This is a randomized double-blind, placebo-controlled, parallel-group study.
The initial visit entails the provision of detailed study information to a subject and obtainment of written informed consent from the subject. The subject will then meet a research team member at a later date for a screening visit. This study requires a total of 12 visits.
Neuropsychological testing will be conducted at 3 time points:
- Baseline (Visit 3)
- Within 60 minutes of the first administration of randomized treatment (Visit 4)
- Endpoint (Visit 12)
- Conditions
- Bipolar Disorder
- Being tested
- Intranasal Insulin, Diluent
- Keywords
- Bipolar Disorder, memory, executive functioning
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal InsulinDrug
Intranasal spray; 40 IU qid; 8 weeks
DiluentDrug
Intranasal spray; 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Intranasal Insulin |
| 2 | Placebo comparator | Not described Receives: Drug: Diluent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Tests: CVLT, Process Dissociation Tasks
Measured: 8 weeks
Secondary outcomes (1)
Cognitive Tests: Trails A
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2006 (estimated)
- Study startMay 2006
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation
- Investigators
- Roger McIntyre, MD, FRCPC, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00314314
- Sponsor's protocol ID
- Insulin
- Status last verified
- May 2008
- First submitted
- 11 Apr 2006
- Last updated
- 13 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Controlled Trial Evaluating the Effect of Intranasal Insulin on Neurocognitive Function in Euthymic Patients With Bipolar Disorder
- ClinicalTrials.gov ID
- NCT00314314
- Acronym / sponsor ID
- Insulin
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Disorder, memory, executive functioning
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Hamilton Health Sciences Corporation
- Study start
- May 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 13 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Sixty verified euthymic individuals (age 18-60) with DSM-IV-TR defined Bipolar Disorder (diagnosis will be confirmed by the Mini International Neuropsychiatric Interview for the DSM-IV) will be enrolled. Individuals below the age of 18 and over 60 are excluded as they are not seen at the recruiting center. Enrollment into the study is voluntary. Eligible subjects will provide written informed consent. Subjects will be enrolled from the outpatient Mood Disorders Psychopharmacology Unit (MDPU), University health Network, University of Toronto. Study information and consent procedures will be provided by personnel other than the primary treatment provider.
Euthymia (the absence of clinically meaningful symptoms) will be prospectively defined as a score of 3 or less with the Hamilton Rating Scale for Depression 7 item (HAMD-7) and a score of 7 or less on the Young Mania Rating Scale (YMRS) at initial assessment and at 1 month (baseline). The HAMD-7 and YMRS will be repeated at every follow-up visit.
Conventional pharmacological treatments for bipolar disorder will be permitted (e.g. Lithium, anticonvulsant mood stabilizers, antipsychotics, antidepressants, anxiolytics/hypnotics, etc.). Medication regimens will remain stable throughout the duration of the study. Enrollment into the study is voluntary. Eligible subjects will provide written informed consent. Study information and consent procedures will be provided by personnel other than the primary treatment provider. Subjects will be enrolled from the outpatient Mood Disorders Psychopharmacology Unit, University Health Network, University of Toronto. Illness characteristics will be obtained from the patient interview and hospital medical records.
Subjects will be compensated for sundry expenses (i.e. parking, public transport). Subjects will not receive financial compensation for being a participant in the study. The ongoing provision of care is not contingent on enrollment and/or completion of the study protocol.
Subjects will be excluded if they are receiving corticosteroids or antihypertensive medications; another current Axis I psychiatric disorder; a neurological or medically unstable condition; substance or alcohol misuse in the past 3 months; or electroconvulsive therapy in the last year. Other exclusion criteria include the presence of diabetes mellitus or hyperglycemia, BMI equal or greater than 40 kg/m^2 or inability to provide written informed consent. Patients who are actively suicidal or evaluated as being a suicide risk will be excluded. Other reasons for discontinuation are voluntary discontinuation, failure to complete 1 month of euthymia, impaired fasting glucose (i.e. 6.1-6.9 mmol/L), non-compliance (i.e. failure to administer > 80% of the assigned treatment in any week). Insulin will be measured quantitatively on a weekly basis; subjects will also complete a diary of when they took intranasal insulin and their prescribed medication.
The ongoing provision of care is not contingent on enrollment and/or completion of the study protocol. Furthermore, there will be ongoing communication with the subject's primary care provider in regards to their participation in this study.
This is a randomized double-blind, placebo-controlled, parallel-group study.
The initial visit entails the provision of detailed study information to a subject and obtainment of written informed consent from the subject. The subject will then meet a research team member at a later date for a screening visit. This study requires a total of 12 visits.
Neuropsychological testing will be conducted at 3 time points:
- Baseline (Visit 3)
- Within 60 minutes of the first administration of randomized treatment (Visit 4)
- Endpoint (Visit 12)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Intranasal Insulin |
| 2 | Placebo comparator | Drug: Diluent |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Bipolar I Disorder - Euthymic
- Bipolar II Disorder - Euthymic
Key exclusion criteria (2 listed)
- Unstable Medical Conditions
- Currently Manic, Depressed or Mixed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intranasal InsulinIntranasal spray; 40 IU qid; 8 weeks | Drug | 1 |
| DiluentIntranasal spray; 8 weeks | Drug | 2 |
Primary outcome
Cognitive Tests: CVLT, Process Dissociation Tasks
Time frame: 8 weeks
1 secondary outcome
Cognitive Tests: Trails A
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger McIntyre, MD, FRCPC principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intranasal Insulin and Diluent in people with Bipolar Disorder, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Tests: CVLT, Process Dissociation Tasks (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2009.