Bipolar DisorderPhase 4NCT03210480
SALT Study (Switching to the Administration of Lithium Slow -Release Treatment)
A Phase 4 study testing Lithium sulphate prolonged-release 660 mg and Lithium carbonate immediate-release 150 mg and 300 mg in people with Bipolar Disorder, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 6 sites in Italy.
Trial summary
The aim of the study is to assess the tolerability, efficacy and safety of a new lithium sulphate prolonged release formulation (Lithiofor®) in patients affected by Bipolar Disorder poor tolerant to lithium immediate-release treatment in terms of lithium-induced tremor when switched from therapy with a lithium… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Lithium sulphate prolonged-release 660 mg and Lithium carbonate immediate-release 150 mg and 300 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 6 sitesItaly
- Study dates
- 28 Mar 2017to 20 Sep 2019
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged 18 to 65 years (limits included), with no limitation of race. Female patients with childbearing potential should have a negative pregnancy test and should not be breastfeeding. Male and female patients should use an appropriate birth control method.
- Diagnosis of Bipolar disorder (BD) I or II (as per DSM-5), with or without rapid cycling.
- BD patients in treatment with lithium Carbolithium® immediate-release, presenting at the screening and baseline low tolerability in terms of tremor (tremor severity assessment ≥ 2 on single item of the UKU side-effect rating scale).
- MADRS score ≤ 10 and YMRS ≤ 12 at screening and baseline visits.
- Patients legally capable to give the consent to participate in the study and available to sign and date the written informed consent.
- Patient able to understand the study procedures and to comply with protocol requirements.
Who cannot join
- Fulfilling criteria for the following disorders: schizophrenia, psychotic and schizoaffective disorders, unipolar depression; concomitant organic mental disorder or intellectual disability; history of dementia or cognitive disorders, any neurodegenerative diseases.
- Known hypersensitivity or allergy to lithium or to any components of the study medications.
- Pharmacological treatments affecting tremor, except for patients treated for at least 2 months before the screening visit (i.e. Beta-blockers; for further details).
- Known tremor due to irreversible lithium neurotoxicity.
- Patients at risk for suicidal behaviour.
- Immunocompromised patients.
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- Acute, or chronic, or recurrent medical conditions that might affect/jeopardize the study results.
- Significant liver disease, defined as known active hepatitis or elevated liver enzymes > 3 times the upper boundary of the normal ranges.
- Value of creatinine outside the normal ranges and judged clinically relevant by Investigator.
- Any contraindication listed in the Summaries of Product Characteristics (SmPC) of Carbolithium® and lithium sulphate prolonged-release tablets (Lithiofor®).
- Positive history for drugs.
- Alcohol abuse.
- Positive urine drug screen for CNS-active drugs (cocaine, opioids, amphetamines and cannabinoids) at Visit 0 (screening).
- Clinically significant abnormalities on physical examination, vital signs, ECG, laboratory tests prior to screening visit.
- Inability to comply with the protocol requirements, instructions and study-related restrictions; e.g. uncooperative attitude, inability to return for study-visits, and improbability of completing the clinical study.
- Vulnerable subjects (e.g. persons kept in detention).
- Participation to an interventional clinical study within 3 months prior to the screening visit.
- If Subject is the Investigator or his(her) deputies, first grade relative, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites
Azienda Ospedaliera Papa Giovanni XXIII - Servizio Psichiatrico di Diagnosi e Cura (SPDC 1)
Bergamo, 24127
IRCCS Azienda Ospedaliera Universitaria San Martino IST - Clinica Psichiatrica
Genova, 16132
Ospedale San Giovanni di Dio di Orbetello Unità Funzionale Salute Mentale
Orbetello, Grosseto, 58016
Azienda Ospedaliera Universitaria Pisana - Psichiatria 1
Pisa, 56126
Azienda Ospedaliera Sant'Andrea - Dip. Di Neuroscienze, Salute mentale e Organi di senso- NESMOS
Roma, 00189
Azienda Ospedaliera Universitaria Senese - Dip. Interaziendale di salute mentale - Psichiatria
Siena, 53100
About this study
Official title: Clinical Evaluation of Switching to Lithiofor® (Lithium Sulphate Slow -Release, Li-SR Tablets) From Carbolithium® (Lithium Carbonate Immediate-Release, Li-IR, Capsules) in Bipolar Patients, Poorly Tolerant to Lithium Immediate-release Treatment.
The aim of the study is to assess the tolerability, efficacy and safety of a new lithium sulphate prolonged release formulation (Lithiofor®) in patients affected by Bipolar Disorder poor tolerant to lithium immediate-release treatment in terms of lithium-induced tremor when switched from therapy with a lithium carbonate immediate release formulation (Carbolithium®) to a new lithium sulphate prolonged release formulation (Lithiofor®).
Read the detailed description
This is a phase IV, randomized, open, parallel groups, multicentre, prospective study.
The main purpose of this clinical trial is to evaluate the change in the lithium induced tremor when switching from Lithium Immediate Release formulation (Carbolithium®) to Lithium Sulphate prolonged-release formulation (Lithiofor®) in Bipolar Disorder patients, poorly tolerant to the Lithium Immediate Release treatment. The primary end point will be the reduction of the lithium induced tremor.
Patients in treatment with lithium carbonate immediate-release (Carbolithium®), will be enrolled in the study and, after 1 week of maintaining treatment, will be randomly switched to Lithium prolonged-release formulation or will continue the previous therapy.
- Conditions
- Bipolar Disorder
- Being tested
- Lithium sulphate prolonged-release 660 mg, Lithium carbonate immediate-release 150 mg and 300 mg
- Keywords
- Lithium Sulphate, Prolonged release formulation, Lithium carbonate, Immediate release formulation, Bipolar Disorder, Tremor
- Medical subject headings
- Bipolar Disorder, Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lithium sulphate prolonged-release 660 mgDrug
Also called LITHIOFOR®
Oral administration of one tablet once or twice daily (one tablet in the morning and one tablet in the evening) or two tablets in a single dose (two tablets in the evening) of Lithium sulphate 660 mg (Lithium sulphate dose will be individualised for each patient according to the relevant SmPC). Treatment duration: 3 months.
Lithium carbonate immediate-release 150 mg and 300 mgDrug
Also called CARBOLITHIUM®
Oral administration of 300-1800 mg daily divided into 2-6 doses of Lithium carbonate capsules (Lithium carbonate dose will be individualised for each patient according to the relevant SmPC). Treatment duration: 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Lithium sulphate prolonged-release 660 mg Receives: Drug: Lithium sulphate prolonged-release 660 mg |
| Group 2 | Active comparator | Lithium carbonate immediate-release 150 mg and 300 mg Receives: Drug: Lithium carbonate immediate-release 150 mg and 300 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of item 2.5 (tremor) in Udvalg for Kliniske Undersøgelser (UKU) scale
Proportion of patients with an improvement in tremor assessed by the change from baseline of item 2.5 in UKU side-effect rating scale after 1-week treatment period.
Measured: Baseline - Week 1
Secondary outcomes (8)
Change of item 2.5 (tremor) in Udvalg for Kliniske Undersøgelser (UKU) scale
Proportion of patients with an improvement in tremor assessed by the change from baseline of item 2.5 in UKU side-effect rating scale after 4- and 12-week treatment period.
Measured: Baseline - Weeks 4 and 12
Change of item 3.8 in Udvalg for Kliniske Undersøgelser (UKU) scale
Proportion of patients with a change from baseline of item 3.8 in UKU side-effect rating scale after 1-, 4- and 12-week treatment period.
Measured: Baseline - Weeks 1, 4 and 12
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
Change from baseline of total score in MADRS scale after 1-, 4- and 12-week treatment period.
Measured: Baseline - Weeks 1, 4 and 12
Change in Young Mania Rating Scale (YMRS)
Change from baseline of total score in YMRS scale after 1-, 4- and 12-week treatment period.
Measured: Baseline - Weeks 1, 4 and 12
Change in Treatment Satisfaction Questionnaire for Medication (TSQM) scale
Change from baseline in each sub-scale of TSQM after 1- and 12-week treatment period.
Measured: Baseline - Weeks 1 and 12
Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF)
Change from baseline in Q-LES-Q-SF after 1- and 12-week treatment period.
Measured: Baseline - Weeks 1 and 12
Change in Clinical Global Impression (CGI) scale
Assessment by the physician of the overall efficacy by CGI scale after 1- and 12-week treatment period.
Measured: Baseline - Weeks 1 and 12
Frequency of treatment-related adverse events
Monitoring of the frequency of adverse events, physical examination, vital signs, ECG, laboratory analyses, plasma Lithium concentration.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2017
- Study start28 Mar 2017
- Primary completion20 Sep 2019
- Study completion20 Sep 2019
Why it stopped: Sponsor's decision due to slow enrollment rate.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, multicenter, prospective study.
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mediolanum Cardio Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03210480
- Sponsor's protocol ID
- 136PO15274
- Other IDs
- 2016-001714-14, 2016
- Status last verified
- Jan 2020
- First submitted
- 23 Jun 2017
- Last updated
- 10 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Switching to Lithiofor® (Lithium Sulphate Slow -Release, Li-SR Tablets) From Carbolithium® (Lithium Carbonate Immediate-Release, Li-IR, Capsules) in Bipolar Patients, Poorly Tolerant to Lithium Immediate-release Treatment.
- ClinicalTrials.gov ID
- NCT03210480
- Acronym / sponsor ID
- 136PO15274
- Conditions
- Bipolar Disorder
- Keywords
- Lithium Sulphate, Prolonged release formulation, Lithium carbonate, Immediate release formulation, Bipolar Disorder, Tremor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's decision due to slow enrollment rate.
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.AIndustry (pharma, biotech, devices)
- Collaborators
- Mediolanum Cardio Research
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 7 Jul 2017 (actual)
- 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 aim of the study is to assess the tolerability, efficacy and safety of a new lithium sulphate prolonged release formulation (Lithiofor®) in patients affected by Bipolar Disorder poor tolerant to lithium immediate-release treatment in terms of lithium-induced tremor when switched from therapy with a lithium carbonate immediate release formulation (Carbolithium®) to a new lithium sulphate prolonged release formulation (Lithiofor®).
Detailed description
This is a phase IV, randomized, open, parallel groups, multicentre, prospective study.
The main purpose of this clinical trial is to evaluate the change in the lithium induced tremor when switching from Lithium Immediate Release formulation (Carbolithium®) to Lithium Sulphate prolonged-release formulation (Lithiofor®) in Bipolar Disorder patients, poorly tolerant to the Lithium Immediate Release treatment. The primary end point will be the reduction of the lithium induced tremor.
Patients in treatment with lithium carbonate immediate-release (Carbolithium®), will be enrolled in the study and, after 1 week of maintaining treatment, will be randomly switched to Lithium prolonged-release formulation or will continue the previous therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, multicenter, prospective study.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Lithium sulphate prolonged-release 660 mgLithium sulphate prolonged-release 660 mg |
| Group 2 | Active comparator | Drug: Lithium carbonate immediate-release 150 mg and 300 mgLithium carbonate immediate-release 150 mg and 300 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients aged 18 to 65 years (limits included), with no limitation of race. Female patients with childbearing potential should have a negative pregnancy test and should not be breastfeeding. Male and female patients should use an appropriate birth control method.
- Diagnosis of Bipolar disorder (BD) I or II (as per DSM-5), with or without rapid cycling.
- BD patients in treatment with lithium Carbolithium® immediate-release, presenting at the screening and baseline low tolerability in terms of tremor (tremor severity assessment ≥ 2 on single item of the UKU side-effect rating scale).
- MADRS score ≤ 10 and YMRS ≤ 12 at screening and baseline visits.
- Patients legally capable to give the consent to participate in the study and available to sign and date the written informed consent.
Key exclusion criteria (18 listed)
- Fulfilling criteria for the following disorders: schizophrenia, psychotic and schizoaffective disorders, unipolar depression; concomitant organic mental disorder or intellectual disability; history of dementia or cognitive disorders, any neurodegenerative diseases.
- Known hypersensitivity or allergy to lithium or to any components of the study medications.
- Pharmacological treatments affecting tremor, except for patients treated for at least 2 months before the screening visit (i.e. Beta-blockers; for further details).
- Known tremor due to irreversible lithium neurotoxicity.
- Patients at risk for suicidal behaviour.
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 sulphate prolonged-release 660 mgAlso: LITHIOFOR®Oral administration of one tablet once or twice daily (one tablet in the morning and one tablet in the evening) or two tablets in a single dose (two tablets in the evening) of Lithium sulphate 660 mg (Lithium sulphate dose will be individualised for each patient according to the relevant SmPC). Treatment duration: 3 months. | Drug | Group 1 |
| Lithium carbonate immediate-release 150 mg and 300 mgAlso: CARBOLITHIUM®Oral administration of 300-1800 mg daily divided into 2-6 doses of Lithium carbonate capsules (Lithium carbonate dose will be individualised for each patient according to the relevant SmPC). Treatment duration: 3 months. | Drug | Group 2 |
Primary outcome
Change of item 2.5 (tremor) in Udvalg for Kliniske Undersøgelser (UKU) scale
Time frame: Baseline - Week 1
Proportion of patients with an improvement in tremor assessed by the change from baseline of item 2.5 in UKU side-effect rating scale after 1-week treatment period.
8 secondary outcomes
Change of item 2.5 (tremor) in Udvalg for Kliniske Undersøgelser (UKU) scale
Time frame: Baseline - Weeks 4 and 12
Change of item 3.8 in Udvalg for Kliniske Undersøgelser (UKU) scale
Time frame: Baseline - Weeks 1, 4 and 12
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Baseline - Weeks 1, 4 and 12
Change in Young Mania Rating Scale (YMRS)
Time frame: Baseline - Weeks 1, 4 and 12
Change in Treatment Satisfaction Questionnaire for Medication (TSQM) scale
Time frame: Baseline - Weeks 1 and 12
Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF)
Time frame: Baseline - Weeks 1 and 12
Change in Clinical Global Impression (CGI) scale
Time frame: Baseline - Weeks 1 and 12
Frequency of treatment-related adverse events
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Sponsor's decision due to slow enrollment rate.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
- Sponsor websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
6 sites 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 sulphate prolonged-release 660 mg and Lithium carbonate immediate-release 150 mg and 300 mg in people with Bipolar Disorder, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 6 sites in Italy.
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 6 inclusion and 18 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 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy. 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?
The study was stopped early (reason given: Sponsor's decision due to slow enrollment rate.). Results are not available in the source record.
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 of item 2.5 (tremor) in Udvalg for Kliniske Undersøgelser (UKU) scale (time frame: Baseline - Week 1). 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 Jan 2020.