Bipolar I DisorderPhase 4NCT01495156
Study of the Efficacy of Adjunctive Lithium Treatment for the Treatment of Psychotic Mania
A Phase 4 study testing Lithium treatment in combination with a SGA (Second Generation Antipsychotic) in people with Bipolar I Disorder, run by Northwell Health at 1 site in United States.
Trial summary
The proposed pilot study is a placebo-controlled, parallel group, randomized clinical trial comparing two treatment strategies in adolescents with mania and prominent psychotic features. One group will receive a second generation antipsychotic (SGA) and placebo and the other will receive a SGA and lithium. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Bipolar I Disorder
- What is being tested?
- Lithium treatment in combination with a SGA (Second Generation Antipsychotic)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Sep 2015
- Phase
- Phase 4
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males and females, 12-18 years old, inpatients or outpatients
- meet DSM-IV criteria for Bipolar I disorder - manic or mixed episode
- psychotic symptoms present
Who cannot join
- current serious homicidal/suicidal ideation
- prior non-response or intolerance to an adequate trial of lithium
- prior non-response or intolerance to adequate trials of both aripiprazole and risperidone
- any unstable medical condition or medical contraindication to treatment with lithium, aripiprazole or risperidone
- inability or unwillingness to discontinue concomitant medication that interferes with the pharmacokinetics of either lithium, aripiprazole, or risperidone
- seizure disorder
Show all 9Show fewer
- pregnant or, if sexually active, not using birth control, such as oral contraceptives, two barrier methods, long-acting depot preparations or an intra-uterine device
- Full Scale IQ less than 70
- meets criteria for a DSM-IV diagnosis of substance-induced mood disorder or mood disorder due to a general medical condition.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Zucker Hillside Hospital, North Shore-LIJ Health System
Glen Oaks, New York, 11004
About this study
Official title: A Randomized, Double-blind, Placebo Controlled Study of the Efficacy of Adjunctive Lithium for the Treatment of Psychotic Mania Followed by an Open Label Long-term Safety Period.
The proposed pilot study is a placebo-controlled, parallel group, randomized clinical trial comparing two treatment strategies in adolescents with mania and prominent psychotic features. One group will receive a second generation antipsychotic (SGA) and placebo and the other will receive a SGA and lithium.
The primary double-blind phase of the study will last 8 weeks, followed by a 24-week extension-phase.
- Conditions
- Bipolar I Disorder
- Being tested
- Lithium treatment in combination with a SGA (Second Generation Antipsychotic), Placebo/Adjunctive SGA treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lithium treatment in combination with a SGA (Second Generation Antipsychotic)Drug
All patients will be treated with aripiprazole with a target dose of 10 mg/day and a max daily dose of 30 mg. If aripiprazole is ineffective or not tolerated, it will be tapered and risperidone treatment will be started. If patient had an adequate aripiprazole trial in the past as described above, risperidone will be the initial treatment. Risperidone dosing will begin with 0.5 mg/day on day 1 with a target dose of 2.5 mg/day and a max daily dose of 6mg.
Subjects in the lithium /adjunctive SGA group will be started at 900 mg/day lithium in thrice daily dosing. The lithium dose will be increased to 1200mg/day on day 4 if lithium has been well-tolerated and symptoms of mania remain, as determined by a phone assessment done by a blinded study physician. The target serum level of lithium will be 1.2 mEq/L (range 0.8 to 1.4 mEq/L).
Placebo/Adjunctive SGA treatmentDrug
All patients will be treated with aripiprazole with a target dose of 10 mg/day and a max daily dose of 30 mg. If aripiprazole is ineffective or not tolerated, it will be tapered and risperidone treatment will be started. If patient had an adequate aripiprazole trial in the past as described above, risperidone will be the initial treatment. Risperidone dosing will begin with 0.5 mg/day on day 1 with a target dose of 2.5 mg/day and a max daily dose of 6mg.
Subjects in the placebo /adjunctive SGA group will receive placebo for the entire trial in addition to the adjunctive SGA.
| Study group | Role | What they receive |
|---|---|---|
| Lithium/Adjunctive SGA | Experimental | Not described Receives: Drug: Lithium treatment in combination with a SGA (Second Generation Antipsychotic) |
| Placebo/Adjunctive SGA | Placebo comparator | Not described Receives: Drug: Placebo/Adjunctive SGA treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute phase :Time to partial or full response
Acute phase: Partial response is defined as at least a 25% -49% reduction in YMRS score and a CGI improvement item score of 2. Full response is defined as a reduction in YMRS score of 50% or more and a CGI improvement item score of 1 "very much improved."
Measured: 8 weeks
Continuation Phase: time to recurrence of a subsyndromal mood episode
We will measure the amount of time for patients to have a recurrance of a subsyndomal mood episode during the Continuation Phase
Measured: 24 weeks
Secondary outcomes (3)
Acute phase: number of suicidal events
Measured: 8 weeks
Acute phase: positive urine toxicology screens (yes/no variable)
Measured: 8 weeks
Acute phase: adherence to medication regimen.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2014 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar I DisorderStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01495156
- Sponsor's protocol ID
- 11-185
- Status last verified
- Jan 2014
- First submitted
- 22 Nov 2011
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled Study of the Efficacy of Adjunctive Lithium for the Treatment of Psychotic Mania Followed by an Open Label Long-term Safety Period.
- ClinicalTrials.gov ID
- NCT01495156
- Acronym / sponsor ID
- 11-185
- Conditions
- Bipolar I Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Sep 2011
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 19 Dec 2011 (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.
The proposed pilot study is a placebo-controlled, parallel group, randomized clinical trial comparing two treatment strategies in adolescents with mania and prominent psychotic features. One group will receive a second generation antipsychotic (SGA) and placebo and the other will receive a SGA and lithium.
The primary double-blind phase of the study will last 8 weeks, followed by a 24-week extension-phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lithium/Adjunctive SGA | Experimental | Drug: Lithium treatment in combination with a SGA (Second Generation Antipsychotic) |
| Placebo/Adjunctive SGA | Placebo comparator | Drug: Placebo/Adjunctive SGA treatment |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Males and females, 12-18 years old, inpatients or outpatients
- meet DSM-IV criteria for Bipolar I disorder - manic or mixed episode
- psychotic symptoms present
Key exclusion criteria (9 listed)
- current serious homicidal/suicidal ideation
- prior non-response or intolerance to an adequate trial of lithium
- prior non-response or intolerance to adequate trials of both aripiprazole and risperidone
- any unstable medical condition or medical contraindication to treatment with lithium, aripiprazole or risperidone
- inability or unwillingness to discontinue concomitant medication that interferes with the pharmacokinetics of either lithium, aripiprazole, or risperidone
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 |
|---|---|---|
| Lithium treatment in combination with a SGA (Second Generation Antipsychotic)All patients will be treated with aripiprazole with a target dose of 10 mg/day and a max daily dose of 30 mg. If aripiprazole is ineffective or not tolerated, it will be tapered and risperidone treatment will be started. If patient had an adequate aripiprazole trial in the past as described above, risperidone will be the initial treatment. Risperidone dosing will begin with 0.5 mg/day on day 1 with a target dose of 2.5 mg/day and a max daily dose of 6mg. Subjects in the lithium /adjunctive SGA group will be started at 900 mg/day lithium in thrice daily dosing. The lithium dose will be increased to 1200mg/day on day 4 if lithium has been well-tolerated and symptoms of mania remain, as determined by a phone assessment done by a blinded study physician. The target serum level of lithium will be 1.2 mEq/L (range 0.8 to 1.4 mEq/L). | Drug | Lithium/Adjunctive SGA |
| Placebo/Adjunctive SGA treatmentAll patients will be treated with aripiprazole with a target dose of 10 mg/day and a max daily dose of 30 mg. If aripiprazole is ineffective or not tolerated, it will be tapered and risperidone treatment will be started. If patient had an adequate aripiprazole trial in the past as described above, risperidone will be the initial treatment. Risperidone dosing will begin with 0.5 mg/day on day 1 with a target dose of 2.5 mg/day and a max daily dose of 6mg. Subjects in the placebo /adjunctive SGA group will receive placebo for the entire trial in addition to the adjunctive SGA. | Drug | Placebo/Adjunctive SGA |
Primary outcome
Acute phase :Time to partial or full response
Time frame: 8 weeks
Acute phase: Partial response is defined as at least a 25% -49% reduction in YMRS score and a CGI improvement item score of 2. Full response is defined as a reduction in YMRS score of 50% or more and a CGI improvement item score of 1 "very much improved."
Continuation Phase: time to recurrence of a subsyndromal mood episode
Time frame: 24 weeks
We will measure the amount of time for patients to have a recurrance of a subsyndomal mood episode during the Continuation Phase
3 secondary outcomes
Acute phase: number of suicidal events
Time frame: 8 weeks
Acute phase: positive urine toxicology screens (yes/no variable)
Time frame: 8 weeks
Acute phase: adherence to medication regimen.
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 treatment in combination with a SGA (Second Generation Antipsychotic) in people with Bipolar I Disorder, run by Northwell Health 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 3 inclusion and 9 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: withdrawn, as of the sponsor's last update on 22 Jan 2014. 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.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Acute phase :Time to partial or full response (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 22 Jan 2014.