DepressionNCT01106313
Insulin Resistance in Patients With Major Depression
An observational study of Depression and Bipolar Disorder, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to study the relationship between insulin and glucose action and neuropsychological functioning (memory, attention, general thinking abilities) in persons with depression. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Depression, Bipolar Disorder, Mood Disorders
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jan 2016
- Phase
- Observational
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Men and women ages 20 to 65 years of age of any ethnic background, with a diagnosis of depression, and whose depressive symptoms are currently in remission
Inclusion Criteria:1)Willingness to sign the Human Subject Protection Consent Form prior to enrollment into the study.
2)Men and women ages 20 to 65 years of age. 3)Diagnosis of unipolar, non-psychotic, non-melancholic major depressive disorder (MDD) or depressive episode of bipolar disorder (Bipolar I, II or NOS), based on a Structured Clinical Interview for DSM-IV Axis I disorders (SCID) and confirmed by a psychiatrist.
- Depression severity as defined by score of <17 on the 21-item Hamilton Rating Scale for Depression and no psychiatric admission within 6 months from study entry and no suicide attempt within the last 12 months.
5)Adequate visual and auditory acuity to allow neuropsychological testing. 6)Stable regime of psychiatric medications for 1 month prior to insulin test. Exclusion Criteria:1)Diagnosis of possible or probable cognitive impairment.
2)For women only: pregnancy, breastfeeding. 3)Personal history of Type I or Type II diabetes. 4) Unstable cardiovascular disease or other major medical condition, or history of myocardial infarction within the previous year.
5)Significant cerebrovascular disease, as evidenced by neurological examination, uncontrolled hypertension (systolic blood pressure > 170 or diastolic blood pressures > 100).
- Current drug or alcohol abuse. 7)History of neurological disorder, e.g. multiple sclerosis, stroke etc. 8)Use of any drug that may significantly affect psychometric testing, or the insulin testing
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
The purpose of this study is to study the relationship between insulin and glucose action and neuropsychological functioning (memory, attention, general thinking abilities) in persons with depression.
- Conditions
- Depression, Bipolar Disorder, Mood Disorders, Insulin Resistance, Depressive Disorder, Major, Depressive Disorder
- Medical subject headings
- Depression, Bipolar Disorder, Mood Disorders, Insulin Resistance, Depressive Disorder, Major, Depressive Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
To quantify insulin-mediated glucose uptake as assessed by the SSPG concentration in patients with depression and compare the values to those previously obtained in a healthy age-matched control population
Measured: Within 3 hours of initial infusion
Secondary outcomes (1)
To examine the association between insulin resistance and cognitive performance and clinical course of depression in patients with depression
Measured: 1 wk
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2010 (estimated)
- Study startJul 2009
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Principal investigator, Natalie Rasgon, Stanford University
- Investigators
- Dr Natalie Rasgon, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01106313
- Sponsor's protocol ID
- SU-02172010-5003
- Other IDs
- eProtocol 17089
- Status last verified
- Oct 2017
- First submitted
- 16 Apr 2010
- Last updated
- 4 Oct 2017
- Results posted
- No
Publications
Wroolie TE, Kenna HA, Singh MK, Rasgon NL. Association between insulin resistance and cognition in patients with depressive disorders: exploratory analyses into age-specific effects. J Psychiatr Res. 2015 Jan;60:65-72. doi: 10.1016/j.jpsychires.2014.10.001. Epub 2014 Oct 14.
PubMed 25455511
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Resistance in Patients With Major Depression
- ClinicalTrials.gov ID
- NCT01106313
- Acronym / sponsor ID
- SU-02172010-5003
- Conditions
- Depression, Bipolar Disorder, Mood Disorders, Insulin Resistance, Depressive Disorder, Major, Depressive Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- Jul 2009
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 19 Apr 2010 (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.
The purpose of this study is to study the relationship between insulin and glucose action and neuropsychological functioning (memory, attention, general thinking abilities) in persons with depression.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women ages 20 to 65 years of age of any ethnic background, with a diagnosis of depression, and whose depressive symptoms are currently in remission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To quantify insulin-mediated glucose uptake as assessed by the SSPG concentration in patients with depression and compare the values to those previously obtained in a healthy age-matched control population
Time frame: Within 3 hours of initial infusion
1 secondary outcome
To examine the association between insulin resistance and cognitive performance and clinical course of depression in patients with depression
Time frame: 1 wk
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 4 Oct 2017.
- Derived from this study: PubMed 25455511Wroolie TE, Kenna HA, Singh MK, Rasgon NL. Association between insulin resistance and cognition in patients with depressive disorders: exploratory analyses into age-specific effects. J Psychiatr Res. 2015 Jan;60:65-72. doi: 10.1016/j.jpsychires.2014.10.001. Epub 2014 Oct 14.
- Stanford Center for Neuroscience in Women's HealthLink provided by the sponsor.
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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.
Dr Natalie Rasgon principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Bipolar Disorder, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 4 Oct 2017. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
To quantify insulin-mediated glucose uptake as assessed by the SSPG concentration in patients with depression and compare the values to those previously obtained in a healthy age-matched control population (time frame: Within 3 hours of initial infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01106313, which also lists 1 linked publication.
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 4 Oct 2017.