Bipolar DisorderPhase 4NCT01811147
Differentiating Unipolar and Bipolar Depression in Young Adults Using fMRI
A Phase 4 study testing Selective Serotonin Reuptake Inhibitor (SSRI) in people with Bipolar Disorder and Major Depression, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of the study is to find out what parts of the brain have increased or decreased activity and connectivity in individuals who have bipolar disorder, major depression, or no history of mood disorder. Read more about this study
- Who is it for?
- Ages 15 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder, Major Depression
- What is being tested?
- Selective Serotonin Reuptake Inhibitor (SSRI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Jun 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Ages 15 - 30 years (inclusive) and able to give voluntary informed consent (parents must also sign consent for subjects under 18)
- Satisfy criteria for Diagnostic and Statistical Manual 4th edition (DSM-IV-TR) for Bipolar I or II disorder
- Satisfy criteria for DSM-IV depressive episode-current
- 17-item Hamilton Depression Rating Scale > 15 but < 25;
- Young Mania Rating Scale score < 10
- Satisfy criteria to undergo an MRI scan based on MRI screening questionnaire.
Show all 23Show fewer
- Able to be managed as outpatients during the study as ascertained by the following - i. Clinical Global Severity Scale < 5 i.e. moderately ill; ii. No significant suicidal or homicidal ideation or grossly disabled.
- Ages 15 - 30 years and able to give voluntary informed consent (Parental consent must also be obtained for those under 18 years old).
- Satisfy criteria for DSM-IV-TR Major Depressive Episode using a Structured Interview
- Never met criteria for mania or hypomania
- 17-item Hamilton Depression Rating Scale score (HDRS) > 15 and < 25.
- Young Mania Rating Scale (YMRS) score < 10
- Satisfy safety criteria to undergo an MRI scan
- Able to be managed as outpatients during the study as ascertained by the following - i. Clinical Global Severity Scale < 5 i.e. moderately ill; ii. No significant suicidal or homicidal ideation or grossly disabled
- ADDITIONAL INCLUSION CRITERIA FOR HIGH RISK UD (HRUD) PATIENTS BESIDE THE INCLUSION CRITERIA FOR UD:
- At least one of the following:
- Family history of bipolar disorder in at least one first degree relative
- History of any sub-threshold hypomania symptoms
- History of mood episode related psychotic symptoms
- ADDITIONAL INCLUSION CRITERIA FOR LOW RISK UD (HRUD) PATIENTS BESIDE THE INCLUSION CRITERIA FOR UD:
- No family history of BD in a first or a second degree relative
- No past history of any sub-threshold hypomania symptoms
- No history of psychotic symptoms
Who cannot join
- Meeting DSM-IV criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, mental retardation, pervasive developmental disorder.
- History of receiving electroconvulsive therapy in the past 1 year
- Use of neuroleptics, mood stabilizers or benzodiazepines in the past 2 weeks.
- Use of antidepressants in the past 2 weeks.
- If on fluoxetine in the past, then should not have been on this medication for 5 weeks.
- Acutely suicidal or homicidal or requiring inpatient treatment.
Show all 21Show fewer
- Meeting DSM-IV criteria for other substance/alcohol dependence within the past 6 months or abuse in the past 3 months, excluding caffeine or nicotine. The criteria will be evaluated by interview and urinary toxicology screening. The use of caffeine or nicotine will be recorded.
- Use of alcohol in the past 1 week before the MRI scan.
- No serious acute or chronic medical or neurological illness, including previously known HIV positive status (due to possible CNS involvement) as assessed by history, physical examination and laboratory examination including EKG, CBC and blood chemistry.
- Current pregnancy or breast feeding.
- Metallic implants or other contraindication to MRI.
- INCLUSION CRITERIA FOR HEALTHY CONTROLS: Healthy subjects matched for age, gender and ethnicity will be included
- Ages 15 - 30 years (inclusive) and able to give voluntary informed consent (Parental consent must also be obtained for those under 18 years old)
- No current or past history of psychiatric illness or substance abuse or dependence.
- No current or past history of psychiatric illness or substance abuse or dependence in a first degree relative.
- Pregnant or breast feeding.
- Metallic implants or other contraindication to MRI.
- Significant family history of psychiatric or neurological illness.
- Currently taking any prescription or centrally acting medications.
- Serious acute or chronic medical or neurological illness as assessed by history, physical examination and laboratory examination including CBC and blood chemistry.
- Use of alcohol in the past 1 week and not being able to avoid alcohol use during the course of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Foundation Center for Behavioral Health
Cleveland, Ohio, 44195
About this study
The purpose of the study is to find out what parts of the brain have increased or decreased activity and connectivity in individuals who have bipolar disorder, major depression, or no history of mood disorder. Another purpose of this study is to use MRI images to determine which young adults with major depression may be at greater risk for developing mild or more severe symptoms of mania which suggests a diagnosis of bipolar disorder.
Read the detailed description
The study involves two phases, phase one includes the screening visit and MRI. The second phase, for depression participants, involves in person follow ups for up to two years. The second phase, for healthy and bipolar participants, involves phone follow ups, every three months for up to two years. The purpose of this study is listed above. We plan to enroll 200 participants total.
- Conditions
- Bipolar Disorder, Major Depression
- Being tested
- Selective Serotonin Reuptake Inhibitor (SSRI)
- Keywords
- Bipolar, Depression, Mania, Hypomania, fMRI, antidepressant
- Medical subject headings
- Bipolar Disorder, Depressive Disorder, Major, Depression, Mania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective Serotonin Reuptake Inhibitor (SSRI)Drug
Also called Serotonin-norepinephrine reuptake inhibitor
Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months.
| Study group | Role | What they receive |
|---|---|---|
| High Risk Depression | Experimental | Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant. Receives: Drug: Selective Serotonin Reuptake Inhibitor (SSRI) |
| Low Risk Depression | Experimental | Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant.. Receives: Drug: Selective Serotonin Reuptake Inhibitor (SSRI) |
| Healthy Control | No intervention | There is no intervention, but rather phone follow ups conducted as check ins to determine the continued eligibility of the healthy control participant. |
| Bipolar | No intervention | Bipolar participants are checked in with via phone conversations every three months, and have the opportunity to be scheduled for non-study visits to manage their symptoms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HAM-D 17 Item: Hamilton Depression Rating Scale
Hamilton depression rating scale (17-item HAM-D):
Scores can range from 0 to 52: No depression (0-7); Mild depression (8-16); Moderate depression (17-23); and Severe depression (≥24).
Measured: 24 months
Secondary outcomes (1)
YMRS: Young Mania Rating Scale
Young Mania Rating Scale: Scores can range from 0 to 60: In Remission/No Mania (0-8); Mild (9-12); Moderate (13-18); Severe (19-25); Very Severe (>25)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2013 (estimated)
- Study startNov 2011
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amit Anand, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01811147
- Sponsor's protocol ID
- IRB 12-1279
- Status last verified
- Nov 2019
- First submitted
- 12 Dec 2011
- Last updated
- 2 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- Undecided
Publications
Koirala P, Hu B, Altinay M, Li M, DiVita AL, Bryant KA, Karne HS, Fiedorowicz JG, Anand A. Sub-threshold bipolar disorder in medication-free young subjects with major depression: Clinical characteristics and antidepressant treatment response. J Psychiatr Res. 2019 Mar;110:1-8. doi: 10.1016/j.jpsychires.2018.12.006. Epub 2018 Dec 8.
PubMed 30579045
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differentiating Unipolar and Bipolar Depression in Young Adults Using fMRI
- ClinicalTrials.gov ID
- NCT01811147
- Acronym / sponsor ID
- IRB 12-1279
- Conditions
- Bipolar Disorder, Major Depression
- Keywords
- Bipolar, Depression, Mania, Hypomania, fMRI, antidepressant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 14 Mar 2013 (estimated)
- Results
- Posted 2 Dec 2019
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 the study is to find out what parts of the brain have increased or decreased activity and connectivity in individuals who have bipolar disorder, major depression, or no history of mood disorder. Another purpose of this study is to use MRI images to determine which young adults with major depression may be at greater risk for developing mild or more severe symptoms of mania which suggests a diagnosis of bipolar disorder.
Detailed description
The study involves two phases, phase one includes the screening visit and MRI. The second phase, for depression participants, involves in person follow ups for up to two years. The second phase, for healthy and bipolar participants, involves phone follow ups, every three months for up to two years. The purpose of this study is listed above. We plan to enroll 200 participants total.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High Risk Depression | Experimental | Drug: Selective Serotonin Reuptake Inhibitor (SSRI)Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant. |
| Low Risk Depression | Experimental | Drug: Selective Serotonin Reuptake Inhibitor (SSRI)Interventions will include the prescribing of Selective serotonin reuptake inhibitor or Serotonin-norepinephrine reuptake inhibitor antidepressants, bupropion or other antidepressant.. |
| Healthy Control | No intervention | –There is no intervention, but rather phone follow ups conducted as check ins to determine the continued eligibility of the healthy control participant. |
| Bipolar | No intervention | –Bipolar participants are checked in with via phone conversations every three months, and have the opportunity to be scheduled for non-study visits to manage their symptoms. |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (23 listed)
- Ages 15 - 30 years (inclusive) and able to give voluntary informed consent (parents must also sign consent for subjects under 18)
- Satisfy criteria for Diagnostic and Statistical Manual 4th edition (DSM-IV-TR) for Bipolar I or II disorder
- Satisfy criteria for DSM-IV depressive episode-current
- 17-item Hamilton Depression Rating Scale > 15 but < 25;
- Young Mania Rating Scale score < 10
Key exclusion criteria (21 listed)
- Meeting DSM-IV criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, mental retardation, pervasive developmental disorder.
- History of receiving electroconvulsive therapy in the past 1 year
- Use of neuroleptics, mood stabilizers or benzodiazepines in the past 2 weeks.
- Use of antidepressants in the past 2 weeks.
- If on fluoxetine in the past, then should not have been on this medication for 5 weeks.
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 |
|---|---|---|
| Selective Serotonin Reuptake Inhibitor (SSRI)Also: Serotonin-norepinephrine reuptake inhibitorSubjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months. | Drug | High Risk Depression, Low Risk Depression |
Primary outcome
HAM-D 17 Item: Hamilton Depression Rating Scale
Time frame: 24 months
Hamilton depression rating scale (17-item HAM-D): Scores can range from 0 to 52: No depression (0-7); Mild depression (8-16); Moderate depression (17-23); and Severe depression (≥24).
1 secondary outcome
YMRS: Young Mania Rating Scale
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30579045Koirala P, Hu B, Altinay M, Li M, DiVita AL, Bryant KA, Karne HS, Fiedorowicz JG, Anand A. Sub-threshold bipolar disorder in medication-free young subjects with major depression: Clinical characteristics and antidepressant treatment response. J Psychiatr Res. 2019 Mar;110:1-8. doi: 10.1016/j.jpsychires.2018.12.006. Epub 2018 Dec 8.
- Individual participant dataSharing planned: Undecided
Related trials for Bipolar Disorder
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
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.
Amit Anand, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Selective Serotonin Reuptake Inhibitor (SSRI) in people with Bipolar Disorder and Major Depression, run by The Cleveland Clinic 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?
The sponsor lists 23 inclusion and 21 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 2 Dec 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
HAM-D 17 Item: Hamilton Depression Rating Scale (time frame: 24 months). 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 NCT01811147, 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 2 Dec 2019.