DepressionNCT01129752
Mothers With a History of Depression and Their 10-14 Year Old Daughters
An observational study of Depression and Depressive Disorder, Major, run by Stanford University at 2 sites in United States.
Trial summary
The purpose of this study is to investigate risk factors associated with depression and how such factors might be transmitted cross-generationally. The investigators are conducting an integrative assessment of emotion regulation and stress reactivity in a group of mothers with and without a history of depression and… Read more about this study
- Who is it for?
- Ages 9 to 15 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression, Depressive Disorder, Major
- How many people
- 240 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2004to Apr 2011
- 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 9 to 15 years
- Women only
- Healthy volunteers accepted
- Child
Study population: Eligible mothers must read and speak English fluently and have a child between the ages of 9 and 15 years old. Mothers must either have no history of psychopathology or have a history of depression during their child's lifetime.
Who may be able to join
- Eligible mothers must read and speak English fluently and have a child between the ages of 9 and 15 years old.
- Mothers must either have no history of psychopathology or have a history of depression during their child's lifetime.
Who cannot join
- Eligible mothers cannot:
- currently be in treatment for drug or alcohol abuse
- have significant symptomatology related to psychopathology outside of depression
- have a medical history of neurological injury or impairment.
- Mothers who meet the requirements for inclusion in the control group must not have a history of any Axis I disorder.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Stanford University Department of Psychology
Stanford, California, 94305
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: The Neural Correlates of Mood and Cognitive Bias in a Population at Risk for Depression: Maternal Cognitive and Emotional Functioning
The purpose of this study is to investigate risk factors associated with depression and how such factors might be transmitted cross-generationally. The investigators are conducting an integrative assessment of emotion regulation and stress reactivity in a group of mothers with and without a history of depression and their daughters.
Read the detailed description
The purpose of this study is to investigate risk factors associated with depression and how such factors might be transmitted cross-generationally. We are conducting an integrative assessment of emotion regulation and stress reactivity in a group of mothers with and without a history of depression and their daughters. We use a range of methodologies to evaluate these processes, including self-report measures, information-processing performance, HPA-axis functioning and reactivity, and neural responses to emotional stimuli following exposure to stressful experiences.
- Conditions
- Depression, Depressive Disorder, Major
- Being tested
- No intervention
- Medical subject headings
- Depression, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
there is no intervention for this study
| Study group | Role | What they receive |
|---|---|---|
| children at risk for depression | children at familial risk for depression Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of depression
participants are interviewed in an 18-month follow-up session
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2010 (estimated)
- Study startFeb 2004
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Ian H Gotlib, PhD, Principal investigator, Stanford University Department of Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01129752
- Sponsor's protocol ID
- SU-03172010-5264
- Other IDs
- 13058
- Status last verified
- Jun 2011
- First submitted
- 21 May 2010
- Last updated
- 23 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neural Correlates of Mood and Cognitive Bias in a Population at Risk for Depression: Maternal Cognitive and Emotional Functioning
- ClinicalTrials.gov ID
- NCT01129752
- Acronym / sponsor ID
- SU-03172010-5264
- Conditions
- Depression, Depressive Disorder, Major
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Feb 2004
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 25 May 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 investigate risk factors associated with depression and how such factors might be transmitted cross-generationally. The investigators are conducting an integrative assessment of emotion regulation and stress reactivity in a group of mothers with and without a history of depression and their daughters.
Detailed description
The purpose of this study is to investigate risk factors associated with depression and how such factors might be transmitted cross-generationally. We are conducting an integrative assessment of emotion regulation and stress reactivity in a group of mothers with and without a history of depression and their daughters. We use a range of methodologies to evaluate these processes, including self-report measures, information-processing performance, HPA-axis functioning and reactivity, and neural responses to emotional stimuli following exposure to stressful experiences.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children at risk for depression | – | Other: No interventionchildren at familial risk for depression |
Who may qualify
- Ages
- 9 to 15 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Eligible mothers must read and speak English fluently and have a child between the ages of 9 and 15 years old. Mothers must either have no history of psychopathology or have a history of depression during their child's lifetime.
Key inclusion criteria (2 listed)
- Eligible mothers must read and speak English fluently and have a child between the ages of 9 and 15 years old.
- Mothers must either have no history of psychopathology or have a history of depression during their child's lifetime.
Key exclusion criteria (5 listed)
- Eligible mothers cannot:
- Mothers who meet the requirements for inclusion in the control group must not have a history of any Axis I disorder.
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 |
|---|---|---|
| No interventionthere is no intervention for this study | Other | children at risk for depression |
Primary outcome
Onset of depression
Time frame: 18 months
participants are interviewed in an 18-month follow-up session
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 23 Jun 2011.
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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.
Ian H Gotlib, PhD principal investigator
Stanford University Department of Psychology
2 sites 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 Depressive Disorder, Major, run by Stanford University at 2 sites 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?
The sponsor lists 2 inclusion and 5 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 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Onset of depression (time frame: 18 months). 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 23 Jun 2011.