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Bipolar DisorderPhase 4NCT02473250

Prediction of Clinical Response to SSRI Treatment in Bipolar Disorder Using Serotonin 1A Receptor PET Imaging

A Phase 4 study testing Fluoxetine and Citalopram in people with Bipolar Disorder, run by New York State Psychiatric Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is for subjects with a diagnosis of bipolar disorder who have depression at the time of recruitment. It involves brain imaging with an MRI (magnetic resonance imaging) and PET scan (positron emission tomography) and treatment with an antidepressant. 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?
Fluoxetine and Citalopram
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
Jan 2015to Dec 2019
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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Ability to provide informed consent
  • Diagnosis of bipolar I disorder or bipolar II disorder and currently meet criteria for a major depressive episode
  • Patients who were on psychiatric medication at presentation will have failed that regimen, as defined as not achieving at least partial remission after an adequate dose of medication for at least six weeks.
  • Depression of sufficient severity to score at least 16 on the first 17 items of the Hamilton Depression Rating Scale
  • Age range 18-60 years
  • Females of child-bearing potential must be willing to use an acceptable method of birth control throughout the study.
  • Subject agrees to discontinue all psychotropic other than those in the PSF and other types of drugs likely to interact with the 5-HT1A receptors.
  • Subject is likely to tolerate medication cross-taper to monotherapy with a mood stabilizer (valproate, lamotrigine or lithium).

Who cannot join

  • Diagnosis of any other major psychiatric disorders such as lifetime schizophrenia, schizoaffective disorder, current psychotic depression or current drug or alcohol abuse (within two months before the study) or recent drug or alcohol dependence (within six months before the study); anorexia nervosa or bulimia nervosa within the last year; IV drug use of ecstasy use more than three times. Meet criteria for a manic episode at the time of screening.
  • Previous failed trial of fluoxetine and citalopram by themselves or in combination with an anti-manic agent, defined as at least six weeks of treatment at the dose of 20 mg per day or more. Failure of two trials of any SSRI or SNRI antidepressant medications.
  • If the patients are discontinuing medications as part of the washout period or are starting valproate, previous failed trial of mood stabilizer that they will take alone.
  • Experienced intolerable side effects of both citalopram and fluoxetine in the past. If the subject is not on medications, intolerable side effects of valproate in the past.
  • History of clinical deterioration when any of the medications that the patient is taking at presentation have been discontinued in the past with the exception of any medications that will be continued during the research protocol.
  • A first-degree family history of schizophrenia if the subject is less than 33 years old
Show all 19Show fewer
  • Significant active physical illness, including blood dyscrasias, lymphomas, hypersplenism, endocrinopathies, renal failure, chronic obstructive lung disease, autonomic neuropathies, peripheral vascular disease, malignancy
  • Actively suicidal, as defined by expressing ideation with a plan for suicide or develops suicidal ideation that requires immediate medication or treatment intervention.
  • Pregnancy, abortion or miscarriage in the two months prior to enrollment or plans to conceive during the course of study participation
  • Lactating women
  • ECT within the past 6 months
  • Subjects who endorse a history of prior head trauma and score 1.5 standard deviations below the mean on Trail-making A \& B will be excluded from study participation.
  • Metal implants, pacemaker, metal prostheses, metal orthodontic appliances or shrapnel in the body
  • Current, past or anticipated exposure to radiation, including:
  • Having been badged for radiation exposure in the workplace
  • Participation in nuclear medicine protocols in the last year. Subjects will be eligible, however, if the injected dose and dosimetry of the radiotracer are known and the cumulative annual exposure of the previous study and this study is lower than the annual limit for research subjects defined by the FDA (21 CFR 361.1)
  • History of claustrophobia that would prevent the participation in imaging scans
  • Current anticoagulant or anti-platelet treatment other than aspirin
  • Obesity with weight >350 lbs or inability to fit into the MRI scanner

Trial locations and contacts

1 site in 1 country.

United States1 site

  • New York State Psychiatric Institute/Columbia University Medical Center

    New York, New York, 10032

Other trials in United States

About this study

This study is for subjects with a diagnosis of bipolar disorder who have depression at the time of recruitment. It involves brain imaging with an MRI (magnetic resonance imaging) and PET scan (positron emission tomography) and treatment with an antidepressant. The medication involves adding an SSRI (either celexa/citalopram or prozac/fluoxetine) to a mood stabilizer.

Read the detailed description

Bipolar disorder is associated with alterations of chemicals in the brain, including one named serotonin. Treatment of depression in bipolar disorder can be accomplished by increasing serotonin function by medications named selective serotonin reuptake inhibitors (SSRI's). Serotonin signals in the brain occur through receptors in a way that is similar to a lock and key, where serotonin is a key and the receptor is a lock. One important receptor is the serotonin 1A (5-HT1A) receptor. This receptor has been found to be abnormal in bipolar disorder during periods of depression, as measured by a type of brain imaging called positron emission tomography (PET). The amount of brain 5-HT1A receptor measured by imaging has also been associated with how well depressed patients with major depressive disorder respond to an SSRI medication. This project will measure the 5-HT1A receptors in bipolar depressed individuals using PET with the radiotracer [11C]-CUMI-101 and will evaluate the ability of this brain imaging signal to predict how patients respond to SSRI treatment when added to a mood stabilizer.

Being tested
Fluoxetine, Citalopram
Medical subject headings
Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FluoxetineDrug

    Also called Prozac

    Bipolar depressed patients will be treated with fluoxetine in combination with a mood stabilizer (valproate).

  • CitalopramDrug

    Also called Celexa

    Bipolar depressed patients will be treated with citalopram in combination with a mood stabilizer (valproate) if fluoxetine is not clinically warranted.

Study groups in NCT02473250
Study groupRoleWhat they receive
Bipolar depressedExperimentalBipolar depressed subjects will have neuroimaging and treatment with fluoxetine in combination with a mood stabilizer (valproate)
Receives: Drug: Fluoxetine; Drug: Citalopram

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Montgomery-Asberg Depression Rating Scale

    Depression severity. Minimum=0, Maximum=60. Higher numbers correspond to greater depression severity. The percent change between week 0 and the last observation was calculated.

    Measured: 6 weeks

Secondary outcomes (3)

  1. Hamilton Anxiety Rating Scale

    Anxiety severity. Minimum=0, Maximum=56. The larger the value on the scale, the more intense the anxiety. The percent difference between week 0 and the last observation was calculated.

    Measured: 6 weeks

  2. Young Mania Rating Scale

    Measure of manic symptoms. Minimum=0, Maximum=60. The higher the value on the scale, the more intense the manic symptoms. The maximum value of YMRS over the six week clinical trial is reported.

    Measured: 6 weeks

  3. Clinical Global Impression-1

    General impression of symptoms by clinician. Minimum=1, Maximum=7. The higher value on the scale, the more symptomatic the patient is. The percent difference between week 0 and the last observation was calculated.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionDec 2019
  4. Study completionDec 2019

Resources

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
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02473250
Sponsor's protocol ID
#7056
Status last verified
Dec 2024
First submitted
10 Jun 2015
Last updated
31 Dec 2024
Data monitoring committee
No

Publications

  • Lan MJ, Pantazatos SP, Ogden RT, Rubin-Falcone H, Hellerstein D, McGrath PJ, Mann JJ. Resting State MRI Amplitude of Low Frequency Fluctuations Associated With Suicidal Ideation in Bipolar Depression. J Clin Psychiatry. 2022 Mar 30;83(3):21m14054. doi: 10.4088/JCP.21m14054.

    PubMed 35377567

  • Lan MJ, Zanderigo F, Pantazatos SP, Sublette ME, Miller J, Ogden RT, Mann JJ. Serotonin 1A Receptor Binding of [11C]CUMI-101 in Bipolar Depression Quantified Using Positron Emission Tomography: Relationship to Psychopathology and Antidepressant Response. Int J Neuropsychopharmacol. 2022 Aug 4;25(7):534-544. doi: 10.1093/ijnp/pyac001.

    PubMed 34996114

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fluoxetine and Citalopram in people with Bipolar Disorder, run by New York State Psychiatric Institute 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 8 inclusion and 19 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 31 Dec 2024. 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 1 Apr 2021). 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?

Montgomery-Asberg Depression Rating Scale (time frame: 6 weeks). 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 NCT02473250, which also lists 2 linked publications.

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 31 Dec 2024.

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