Bipolar DepressionNCT00566150

Levetiracetam in the Management of Bipolar Depression

A study testing Levetiracetam in people with Bipolar Depression, run by Yale University at 1 site in United States.

Completed

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

Trial summary

A 6-week outpatient, double-blind, placebo-controlled, add-on trial to investigate the effects of levetiracetam on depressive symptoms in bipolar depressed patients. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Bipolar Depression
What is being tested?: Levetiracetam
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 35 participants
Where: 1 siteUnited States
Study dates: Oct 2005to Aug 2008
Phase: Interventional
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

DSM-IV diagnosis of bipolar disorder
Presence of a current major depressive episode on the SCID
Score of 17 or great on the HDRS
Capable of giving voluntary written consent

Who cannot join

Significant current substance dependence/abuse within 3 months preceding the trial
Active suicidal ideation
Pregnant/lactating mothers
Significant medical history

Trial locations and contacts

1 site in 1 country.

United States1 site

Yale University School of Medicine
New Haven, Connecticut, 06519

Other trials in United States

About this study

A 6-week outpatient, double-blind, placebo-controlled, add-on trial to investigate the effects of levetiracetam on depressive symptoms in bipolar depressed patients.

Conditions: Bipolar Depression
Being tested: Levetiracetam, Placebo
Keywords: Keppra, Levetiracetam, Anticonvulsant, Depression, Bipolar Disorder, Affective Disorders, Mood Disorders, Double Blind, Acute Antidepressant Effects
Medical subject headings: Bipolar Disorder, Depression, Mood Disorders

What participants receive

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

LevetiracetamDrug
Also called Keppra
Flexible dose up to 2500mg per day, for 6 weeks.
PlaceboDrug
Flexible dose up to 2500mg per day, for 6 weeks.

Study groups in NCT00566150
Study group	Role	What they receive
Levetiracetam	Active comparator	Not described Receives: Drug: Levetiracetam
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Change in Hamilton Depression Rating Scale (HDRS-21) Total Score From Baseline at Week 6.
Change is observed value at each visit minus baseline value. HDRS-21 is a 21-item instrument measuring depression. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 60.
Measured: Baseline to week 6

Secondary outcomes (3)

Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline at Week 6.
Change is observed value at each visit minus baseline value. MADRS is a 10-item instrument measuring depression: scale range between 0(normal) - 6(most abnormal)for each item. Total possible score is 0 - 60.
Measured: Baseline to week 6
Number of Subjects Who Achieve Remission.
Remission response is measured as an HDRS-21 total score is less than or equal to 7.
HDRS-21 measures range of depressive symptoms. Endpoint is LOCF.
Measured: Week 6
Change in Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP) Depression Severity Rating From Baseline at Week 6.
Change is observed value at each visit minus baseline value. CGI-BP depression severity is an instrument which measures severity of depression in bipolar disorder. Scale range: 1=normal, not ill; 7=very severely ill
Measured: Baseline to week 6

Timeline

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

Oct 2005Aug 2008

First posted3 Dec 2007 (estimated)
Study startOct 2005
Primary completionAug 2008
Study completionAug 2008

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 (2)Papers the sponsor has linked to this study.
Other trials for Bipolar DepressionStudies of the same condition, open and under way.
More trials run by Yale 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00566150
Sponsor's protocol ID: 0508000506
Status last verified: Aug 2016
First submitted: 29 Nov 2007
Last updated: 31 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Muralidharan A, Bhagwagar Z. Potential of levetiracetam in mood disorders: a preliminary review. CNS Drugs. 2006;20(12):969-79. doi: 10.2165/00023210-200620120-00002.
PubMed 17140277
Saricicek A, Maloney K, Muralidharan A, Ruf B, Blumberg HP, Sanacora G, Lorberg B, Pittman B, Bhagwagar Z. Levetiracetam in the management of bipolar depression: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2011 Jun;72(6):744-50. doi: 10.4088/JCP.09m05659gre. Epub 2010 Oct 19.
PubMed 21034692

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

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Safety and Feasibility of DBS for Bipolar Depression
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All Bipolar Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Levetiracetam in the Management of Bipolar Depression
ClinicalTrials.gov ID: NCT00566150
Acronym / sponsor ID: 0508000506
Conditions: Bipolar Depression
Keywords: Keppra, Levetiracetam, Anticonvulsant, Depression, Bipolar Disorder, Affective Disorders, Mood Disorders, Double Blind
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: Stanley Medical Research Institute
Study start: Oct 2005
Primary completion: Aug 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 3 Dec 2007 (estimated)
Results: Posted 2 Nov 2015

Clinical summary

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

A 6-week outpatient, double-blind, placebo-controlled, add-on trial to investigate the effects of levetiracetam on depressive symptoms in bipolar depressed patients.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Levetiracetam	Active comparator	Drug: Levetiracetam
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

DSM-IV diagnosis of bipolar disorder
Presence of a current major depressive episode on the SCID
Score of 17 or great on the HDRS
Capable of giving voluntary written consent

Key exclusion criteria (4 listed)

Significant current substance dependence/abuse within 3 months preceding the trial
Active suicidal ideation
Pregnant/lactating mothers
Significant medical history

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
LevetiracetamAlso: KeppraFlexible dose up to 2500mg per day, for 6 weeks.	Drug	Levetiracetam
PlaceboFlexible dose up to 2500mg per day, for 6 weeks.	Drug	Placebo

Primary outcome

Change in Hamilton Depression Rating Scale (HDRS-21) Total Score From Baseline at Week 6.
Time frame: Baseline to week 6
Change is observed value at each visit minus baseline value. HDRS-21 is a 21-item instrument measuring depression. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 60.

3 secondary outcomes

Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline at Week 6.
Time frame: Baseline to week 6
Number of Subjects Who Achieve Remission.
Time frame: Week 6
Change in Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP) Depression Severity Rating From Baseline at Week 6.
Time frame: Baseline to week 6

Results and safety

Results posted to the registry on 2 Nov 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Levetiracetam	19	10
Placebo	16	11

Primary outcome: Change in Hamilton Depression Rating Scale (HDRS-21) Total Score From Baseline at Week 6.

Time frame: Baseline to week 6. Least squares mean (Standard Error). Unit: score on scale

Measure	Levetiracetam n = 17	Placebo n = 15
Week 1 (n=17, n=15)	-2.7647 (1.4138)	-4 (1.5051)
Week 2 (n=15, n=14)	-3.4259 (1.4618)	-6.5875 (1.5327)
Week 3 (n=13, n=14)	-2.1243 (1.5441)	-6.3625 (1.5458)
Week 4 (n=11, n=13)	-4.3534 (1.6582)	-6.3851 (1.583)
Week 5 (n=11, n=13)	-6.952 (1.7105)	-6.4368 (1.6006)
Week 6 (n=10, n=11)	-4.8136 (1.7806)	-7.0712 (1.6838)

Levetiracetam vs Placebo: p = 0.29, Mixed Models Analysis

Population analysed: Weeks 1-6 are Intent to treat (ITT) population Observed Cases. All participants included received at least 1 dose of study intervention and at least 1 assessment post-baseline.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected during course of the study and for two weeks after last study intervention.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Levetiracetam	0 of 19 (0%)	17 of 19 (89.5%)	Not reported
Placebo	0 of 16 (0%)	15 of 16 (93.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17140277Muralidharan A, Bhagwagar Z. Potential of levetiracetam in mood disorders: a preliminary review. CNS Drugs. 2006;20(12):969-79. doi: 10.2165/00023210-200620120-00002.
Derived from this study: PubMed 21034692Saricicek A, Maloney K, Muralidharan A, Ruf B, Blumberg HP, Sanacora G, Lorberg B, Pittman B, Bhagwagar Z. Levetiracetam in the management of bipolar depression: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2011 Jun;72(6):744-50. doi: 10.4088/JCP.09m05659gre. Epub 2010 Oct 19.

Related trials for Bipolar Depression

Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
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
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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
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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.

Zubin Bhagwagar, MD PhD principal investigator

Yale University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Levetiracetam in people with Bipolar Depression, run by Yale 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?

The sponsor lists 4 inclusion and 4 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 Mar 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 2 Nov 2015). 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 Hamilton Depression Rating Scale (HDRS-21) Total Score From Baseline at Week 6. (time frame: Baseline to week 6). 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 NCT00566150, 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 Mar 2020.