Bipolar DisorderPhase 3NCT00276965
Bipolar II Depression: Lithium, SSRI, or the Combination
A Phase 3 study testing Sertraline and Lithium carbonate in people with Bipolar Disorder and Depression, run by Lindner Center of HOPE at 3 sites in United States.
Trial summary
This study will compare the safety and effectiveness of a mood stabilizing medication, an antidepressant medication, and a combination of both medications to treat symptoms of bipolar type II depression. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder, Depression
- What is being tested?
- Sertraline and Lithium carbonate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2006to Jul 2012
- Phase
- Phase 3
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets DSM-IV criteria for bipolar type II disorder by Structured Clinical Interview for DSM-IV (SCID)
- Meets DSM-IV criteria for current depressive episode
- Inventory of Depressive Symptomology (IDS-C) score greater than 22
- Clinical Global Impression Scale for Bipolar Illness (CGI-BP) depression subscale score greater than 3 (mildly ill or greater) and mania subscale score of 1 (not ill)
- Young Mania Rating Scale (YMRS) score less than 8
- Willing to discontinue antidepressant medication
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- Considered stable and does not require adjustments in treatment for other conditions or illnesses
- Willing to use an effective form of birth control throughout the study
- Speaks English
Who cannot join
- Pregnant or breastfeeding
- Unsuccessfully treated for more than 6 weeks with sertraline or lithium for depression
- Suicidal
- Significant alcohol or substance abuse or dependence within 3 months of study entry
- Diagnosed with Axis II borderline personality disorder
- Psychotic
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- Organic mood disorder (e.g., head trauma or cerebrovascular accident preceding mood episode)
- Active hepatitis, liver failure, or kidney failure
- Creatinine greater than 1 mg/dL
- Liver function tests greater than 3 times the upper limit of normal
- Abnormal thyroid-stimulating hormone
- Unstable medical condition
Trial locations and contacts
3 sites in 1 country.
United States3 sites
UCLA
Los Angeles, California, 90095
Lindner Center of HOPE, affliated with University of Cincinnati Medical Center
Mason, Ohio, 45040
Stanford University - Bipolar Research Program
Palo Alto, California, 94304
About this study
Official title: Comparing the Safety and Effectiveness of a Mood Stabilizing Medication, an Antidepressant Medication, and a Combination of Both Medications to Treat Symptoms of Bipolar Type II Depression
This study will compare the safety and effectiveness of a mood stabilizing medication, an antidepressant medication, and a combination of both medications to treat symptoms of bipolar type II depression.
Read the detailed description
Bipolar type II depression (BD II) is a less severe type of bipolar disorder. BD II is characterized by one or more depressive episodes and at least one hypomanic episode. During hypomanic episodes, people experience especially energetic or anxious moods, and their thoughts are more sporadic than usual, but they do not experience the severity of mania. Symptoms of BD II are known to impair daily functioning as well as cause distress and even suicide. Antidepressant medication alone is not recommended for people with bipolar disorder because manic symptoms usually worsen. It is unknown whether the same recommendation should apply to people with BD II. Sertraline is a selective serotonin reuptake inhibitor (SSRI) antidepressant that increases levels of serotonin, helping the brain to maintain mental stability. It is often used to treat depression, panic attacks, and other disorders. Lithium is a mood stabilizing medication that decreases abnormal brain activity and is used to treat and prevent recurring episodes of mania in people with bipolar disorders. This study will evaluate the effectiveness of lithium alone, sertraline alone, and lithium with sertraline to treat symptoms of BD II.
Participation in this double-blind study will last up to 18 weeks. Participants will be randomly assigned to receive either lithium, sertraline, or lithium and sertraline. Both medications will initially be given at a low dose and then gradually increased over 2 weeks. For the remainder of the study, dosages will be adjusted as necessary. Study visits will occur every week for the first 6 weeks and then every other week for the remaining 10 weeks. During all study visits, participants will complete a psychiatric assessment and questionnaires about their current mood and any treatment side effects. Urine and blood collection may occur at selected times during the study.
- Conditions
- Bipolar Disorder, Depression
- Being tested
- Sertraline, Lithium carbonate
- Keywords
- Bipolar II Depression
- Medical subject headings
- Bipolar Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
Also called Zoloft
Sertraline or placebo for sertraline starting at 25 mg per day, up to maximum of 200 mg per day
Lithium carbonateDrug
Also called Eskalith, Lithobid
Lithium or placebo for lithium starting at 150 mg per day; target dose of 900mg per day. Maximum dose based on clinical response and serum levels (maximum serum level of 1.2 mEq/L).
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Participants will take lithium only. Receives: Drug: Lithium carbonate |
| B | Experimental | Participants will take lithium and sertraline. Receives: Drug: Sertraline; Drug: Lithium carbonate |
| C | Experimental | Participants will take sertraline only. Receives: Drug: Sertraline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine switch rate to Mania/hypomania
Measured: Measured at week 16
Secondary outcomes (3)
Side effects
Measured: Measured at week 16
Antidepressant response
Measured: Measured at week 16
Mood variability
Measured: Measured at week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2006 (estimated)
- Study startSep 2006
- Primary completionMar 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lindner Center of HOPE
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of California, Los Angeles, Stanford University
- Responsible party
- Sponsor
- Investigators
- Lori Altshuler, MD, Principal investigator, UCLA Mood Disorders Research Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00276965
- Sponsor's protocol ID
- R01MH074707
- Other IDs
- R01MH074707, DATR A5-ETMA
- Status last verified
- May 2013
- First submitted
- 12 Jan 2006
- Last updated
- 10 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Safety and Effectiveness of a Mood Stabilizing Medication, an Antidepressant Medication, and a Combination of Both Medications to Treat Symptoms of Bipolar Type II Depression
- ClinicalTrials.gov ID
- NCT00276965
- Acronym / sponsor ID
- R01MH074707
- Conditions
- Bipolar Disorder, Depression
- Keywords
- Bipolar II Depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Lindner Center of HOPEUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of California, Los Angeles, Stanford University
- Study start
- Sep 2006
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 13 Jan 2006 (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.
This study will compare the safety and effectiveness of a mood stabilizing medication, an antidepressant medication, and a combination of both medications to treat symptoms of bipolar type II depression.
Detailed description
Bipolar type II depression (BD II) is a less severe type of bipolar disorder. BD II is characterized by one or more depressive episodes and at least one hypomanic episode. During hypomanic episodes, people experience especially energetic or anxious moods, and their thoughts are more sporadic than usual, but they do not experience the severity of mania. Symptoms of BD II are known to impair daily functioning as well as cause distress and even suicide. Antidepressant medication alone is not recommended for people with bipolar disorder because manic symptoms usually worsen. It is unknown whether the same recommendation should apply to people with BD II. Sertraline is a selective serotonin reuptake inhibitor (SSRI) antidepressant that increases levels of serotonin, helping the brain to maintain mental stability. It is often used to treat depression, panic attacks, and other disorders. Lithium is a mood stabilizing medication that decreases abnormal brain activity and is used to treat and prevent recurring episodes of mania in people with bipolar disorders. This study will evaluate the effectiveness of lithium alone, sertraline alone, and lithium with sertraline to treat symptoms of BD II.
Participation in this double-blind study will last up to 18 weeks. Participants will be randomly assigned to receive either lithium, sertraline, or lithium and sertraline. Both medications will initially be given at a low dose and then gradually increased over 2 weeks. For the remainder of the study, dosages will be adjusted as necessary. Study visits will occur every week for the first 6 weeks and then every other week for the remaining 10 weeks. During all study visits, participants will complete a psychiatric assessment and questionnaires about their current mood and any treatment side effects. Urine and blood collection may occur at selected times during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Lithium carbonateParticipants will take lithium only. |
| B | Experimental | Drug: Sertraline, Drug: Lithium carbonateParticipants will take lithium and sertraline. |
| C | Experimental | Drug: SertralineParticipants will take sertraline only. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Meets DSM-IV criteria for bipolar type II disorder by Structured Clinical Interview for DSM-IV (SCID)
- Meets DSM-IV criteria for current depressive episode
- Inventory of Depressive Symptomology (IDS-C) score greater than 22
- Clinical Global Impression Scale for Bipolar Illness (CGI-BP) depression subscale score greater than 3 (mildly ill or greater) and mania subscale score of 1 (not ill)
- Young Mania Rating Scale (YMRS) score less than 8
Key exclusion criteria (12 listed)
- Pregnant or breastfeeding
- Unsuccessfully treated for more than 6 weeks with sertraline or lithium for depression
- Suicidal
- Significant alcohol or substance abuse or dependence within 3 months of study entry
- Diagnosed with Axis II borderline personality 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 |
|---|---|---|
| SertralineAlso: ZoloftSertraline or placebo for sertraline starting at 25 mg per day, up to maximum of 200 mg per day | Drug | B, C |
| Lithium carbonateAlso: Eskalith, LithobidLithium or placebo for lithium starting at 150 mg per day; target dose of 900mg per day. Maximum dose based on clinical response and serum levels (maximum serum level of 1.2 mEq/L). | Drug | A, B |
Primary outcome
Determine switch rate to Mania/hypomania
Time frame: Measured at week 16
3 secondary outcomes
Side effects
Time frame: Measured at week 16
Antidepressant response
Time frame: Measured at week 16
Mood variability
Time frame: Measured at week 16
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 10 May 2013.
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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.
Lori Altshuler, MD principal investigator
UCLA Mood Disorders Research Program
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sertraline and Lithium carbonate in people with Bipolar Disorder and Depression, run by Lindner Center of HOPE at 3 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 9 inclusion and 12 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 10 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Determine switch rate to Mania/hypomania (time frame: Measured at week 16). 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 10 May 2013; AzTrials last refreshed its copy on 1 Nov 2026.