Bipolar DisorderPhase 4NCT02909504

Gao NARASD Lithium Study

A Phase 4 study testing Lithium in people with Bipolar Disorder, run by Keming Gao at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Bipolar Disorder
What is being tested?: Lithium
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: Sep 2016to Nov 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 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

For inclusion in this study, subjects must meet all of the following criteria:
Able to provide informed consent before beginning any study-specific procedures;
Male or female, 18-70 years old;
Meets current DSM-5 criteria for bipolar I or II disorder as assessed by the The M.I.N.I. International Neuropsychiatric Interview (MINI);
Any symptomatic phase of bipolar I or II disorder including, depressive, manic, mixed or hypomanic
Global Clinical Impression-Severity for Bipolar Disorder (CGI-S-BD) ≥3;

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Willing to take lithium;
If a sexually active female of childbearing potential, be using a reliable method of contraception;
Women with reproductive potential must have a negative urine pregnancy test;
Willing to have blood drawn:

Who cannot join

Any of the following is regarded as a criterion for exclusion from the study:
Unwilling to comply with study requirements;
Renal impairment (serum creatinine >1.5 mg/dL);
Thyroid stimulating hormone (TSH) over >20% above the upper normal limit (participants maintained on thyroid medication must be euthyroid for at least 3 months before Visit 1;
Other contraindication to lithium,
Patients who have had severe adverse reaction to Lithium;

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Patients who require inpatient care;
Drug/alcohol dependence requiring immediate acute detoxification;
Pregnancy as determined by serum pregnancy test or breastfeeding;
History of nonresponse to lithium at doses ≥ 900 mg/d for ≥ 8 weeks;
Unwilling to have blood drawn
Patients with chronic medical conditions such as diabetes, coronary artery disease, immune diseases, infectious diseases and neurological disorders;
Active suicidal ideation with a plan or intent, a suicide attempt within past 6 months or more than 2 suicide attempts within the past 2 years.
Currently on lithium

Trial locations and contacts

1 site in 1 country.

United States1 site

University Hospitals Cleveland Medical Center Department of Psychiatry
Cleveland, Ohio, 44106

Other trials in United States

About this study

Official title: Biomarkers in Mononuclear Blood Cells for Lithium Treatment Response of Bipolar Disorder

This study is a 4-month open-label study of lithium in the acute treatment of patients with bipolar I or II disorder. Eligible patients will receive lithium 300 mg twice daily and titrated in 300 mg increments every 7 days as tolerated to levels > 0.6 mEq/L. Blood samples are collected at baseline and at the end of study. Analyses of 45 molecule expressions in mononuclear blood cells at baseline and endpoint will be carried out after the completion of study. Fifty patients meeting Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) criteria for bipolar I or II will be enrolled.

Conditions: Bipolar Disorder
Being tested: Lithium
Medical subject headings: Bipolar Disorder

What participants receive

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

LithiumDrug
Eligible patients will receive lithium 300 mg twice daily and titrated in 300 mg increments every 7 days as tolerated to levels > 0.6 mEq/L

Study groups in NCT02909504
Study group	Role	What they receive
Lithium	Other	Eligible patients will receive lithium 300 mg twice daily and titrated in 300 mg increments every 7 days as tolerated to levels > 0.6 mEq/L Receives: Drug: Lithium

What is being measured

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

Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium
Molecule expression is measured as a function of relative fluorescence intensity. The number derives from a photomultiplier tube which essentially counts photons. Higher numbers mean a higher intensity. The values in the results tables represents change in fluorescence intensity between Baseline and Week 16 across various molecules of interest and compares responders (those who experience a >=50% decrease in mood symptom severity between baseline and week 16) and non responders (those who did NOT experience a >=50% decrease in mood symptom severity between baseline and week 16). The rows represent the various molecules that were analyzed.
Measured: Baseline and Week 16

Timeline

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

Sep 2016Nov 2018

First posted21 Sep 2016 (estimated)
Study startSep 2016
Primary completionNov 2018
Study completionNov 2018

Why it stopped: Lack of funding

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.
Other trials for Bipolar DisorderStudies of the same condition, open and under way.
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: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02909504
Sponsor's protocol ID: 07-16-05
Status last verified: Jun 2020
First submitted: 19 Sep 2016
Last updated: 10 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine
Mania, Bipolar Disorder
RecruitingPhase 3
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
Bipolar Depression
RecruitingObservational study
Natural History of Depression, Bipolar Disorder and Suicide Risk
Behavioral Symptoms, Suicide
RecruitingPhase 3
Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
Schizophrenia, Bipolar Disorder
Recruiting
Evaluation of the Impact of the EDIT-B® Blood Test on the Health Status of Patients Presenting a Major Depressive Episode. Clinical Utility and Medico-Economic Aspects
Bipolar Disorder, Major Depressive Disorder

All Bipolar Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Biomarkers in Mononuclear Blood Cells for Lithium Treatment Response of Bipolar Disorder
ClinicalTrials.gov ID: NCT02909504
Acronym / sponsor ID: 07-16-05
Conditions: Bipolar Disorder
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Lack of funding
Enrolment: 24 participants (actual)
Lead sponsor: Keming GaoUniversity, hospital or other
Collaborators: CellPrint Biotechnology, National Alliance for Research on Schizophrenia and Depression
Study start: Sep 2016
Primary completion: Nov 2018 (actual)
Study completion: Nov 2018 (actual)
First posted: 21 Sep 2016 (estimated)
Results: Posted 10 Jul 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Lithium	Other	Drug: LithiumEligible patients will receive lithium 300 mg twice daily and titrated in 300 mg increments every 7 days as tolerated to levels > 0.6 mEq/L

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Able to provide informed consent before beginning any study-specific procedures;
Male or female, 18-70 years old;
Meets current DSM-5 criteria for bipolar I or II disorder as assessed by the The M.I.N.I. International Neuropsychiatric Interview (MINI);
Any symptomatic phase of bipolar I or II disorder including, depressive, manic, mixed or hypomanic
Global Clinical Impression-Severity for Bipolar Disorder (CGI-S-BD) ≥3;

Key exclusion criteria (14 listed)

Unwilling to comply with study requirements;
Renal impairment (serum creatinine >1.5 mg/dL);
Thyroid stimulating hormone (TSH) over >20% above the upper normal limit (participants maintained on thyroid medication must be euthyroid for at least 3 months before Visit 1;
Other contraindication to lithium,
Patients who have had severe adverse reaction to Lithium;

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
LithiumEligible patients will receive lithium 300 mg twice daily and titrated in 300 mg increments every 7 days as tolerated to levels > 0.6 mEq/L	Drug	Lithium

Primary outcome

Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium
Time frame: Baseline and Week 16
Molecule expression is measured as a function of relative fluorescence intensity. The number derives from a photomultiplier tube which essentially counts photons. Higher numbers mean a higher intensity. The values in the results tables represents change in fluorescence intensity between Baseline and Week 16 across various molecules of interest and compares responders (those who experience a >=50% decrease in mood symptom severity between baseline and week 16) and non responders (those who did NOT experience a >=50% decrease in mood symptom severity between baseline and week 16). The rows represent the various molecules that were analyzed.

Results and safety

Results posted to the registry on 10 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lithium	24	12

Primary outcome: Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium

Time frame: Baseline and Week 16. Mean (Standard Deviation). Unit: fluorescence intensity

Measure	Lithium Non Responders n = 9	Lithium Responders n = 12
NLRP3	30.73 (5.66)	26.00 (7.25)
PDEB4	28.15 (9.12)	27.31 (5.78)
BAK	11.16 (2.08)	11.50 (2.88)
p-Fyn Yes	12.49 (4.46)	13.33 (6.44)
HMGB1	23.18 (8.69)	22.61 (6.58)
IRS2	25.29 (5.64)	24.06 (8.71)
p-CREB	30.78 (4.34)	30.46 (6.55)
PPAR g	21.90 (4.31)	21.13 (5.62)

Population analysed: While we planned to analyze \~45 molecules of interest, poor quality of antibodies to some proteins \& financial limitations limited us to only 28 proteins. The number of participants analyzed for protein expression differs from baseline characteristic and varies below as not all subjects had high enough levels of a particular protein to be analyzed.

Adverse events

Time frame: 16 weeks. Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lithium	0 of 24 (0%)	20 of 24 (83.3%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Bipolar Disorder

RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine
Mania, Bipolar Disorder
RecruitingPhase 3
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
Bipolar Depression
RecruitingObservational study
Natural History of Depression, Bipolar Disorder and Suicide Risk
Behavioral Symptoms, Suicide
RecruitingPhase 3
Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
Schizophrenia, Bipolar Disorder
Recruiting
Evaluation of the Impact of the EDIT-B® Blood Test on the Health Status of Patients Presenting a Major Depressive Episode. Clinical Utility and Medico-Economic Aspects
Bipolar Disorder, Major Depressive Disorder

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.

Keming Gao, MD, PhD principal investigator

University Hospitals Cleveland Medical Center

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 Lithium in people with Bipolar Disorder, run by Keming Gao 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 10 inclusion and 14 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: stopped early, as of the sponsor's last update on 10 Jul 2020. 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 10 Jul 2020). 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?

Change in Expression of ~45 Molecules in Blood Cells of Patients With Bipolar I or II Disorder Being Treated With Lithium (time frame: Baseline and Week 16). 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 NCT02909504.

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 10 Jul 2020.