SALT Study (Switching to the Administration of Lithium Slow -Release Treatment)

NCT ID: NCT03210480

Last Updated: 2020-01-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-28
• Study Completion Date: 2019-09-20

Brief 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 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.

Conditions

Bipolar Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

Lithium sulphate prolonged-release 660 mg

Group Type: EXPERIMENTAL

Lithium sulphate prolonged-release 660 mg

Intervention Type: DRUG

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.

Group 2

Lithium carbonate immediate-release 150 mg and 300 mg

Group Type: ACTIVE_COMPARATOR

Lithium carbonate immediate-release 150 mg and 300 mg

Intervention Type: DRUG

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.

Interventions

Lithium sulphate prolonged-release 660 mg

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.

Intervention Type: DRUG

Lithium carbonate immediate-release 150 mg and 300 mg

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.

Intervention Type: DRUG

Other Intervention Names

LITHIOFOR®; CARBOLITHIUM®

Eligibility Criteria

Inclusion Criteria

1. 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.

2. Diagnosis of Bipolar disorder (BD) I or II (as per DSM-5), with or without rapid cycling.

3. 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).

4. MADRS score ≤ 10 and YMRS ≤ 12 at screening and baseline visits.

5. Patients legally capable to give the consent to participate in the study and available to sign and date the written informed consent.

6. Patient able to understand the study procedures and to comply with protocol requirements.

Exclusion Criteria

1. 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.

2. Known hypersensitivity or allergy to lithium or to any components of the study medications.

3. Pharmacological treatments affecting tremor, except for patients treated for at least 2 months before the screening visit (i.e. Beta-blockers; for further details).

4. Known tremor due to irreversible lithium neurotoxicity.

5. Patients at risk for suicidal behaviour.

6. Immunocompromised patients.

7. Acute, or chronic, or recurrent medical conditions that might affect/jeopardize the study results.

8. Significant liver disease, defined as known active hepatitis or elevated liver enzymes > 3 times the upper boundary of the normal ranges.

9. Value of creatinine outside the normal ranges and judged clinically relevant by Investigator.

10. Any contraindication listed in the Summaries of Product Characteristics (SmPC) of Carbolithium® and lithium sulphate prolonged-release tablets (Lithiofor®).

11. Positive history for drugs.

12. Alcohol abuse.

13. Positive urine drug screen for CNS-active drugs (cocaine, opioids, amphetamines and cannabinoids) at Visit 0 (screening).

14. Clinically significant abnormalities on physical examination, vital signs, ECG, laboratory tests prior to screening visit.

15. 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.

16. Vulnerable subjects (e.g. persons kept in detention).

17. Participation to an interventional clinical study within 3 months prior to the screening visit.

18. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mediolanum Cardio Research

OTHER

Sponsor Role: collaborator

Aziende Chimiche Riunite Angelini Francesco S.p.A

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ospedale San Giovanni di Dio di Orbetello Unità Funzionale Salute Mentale

Orbetello, Grosseto, Italy

Azienda Ospedaliera Papa Giovanni XXIII - Servizio Psichiatrico di Diagnosi e Cura (SPDC 1)

Bergamo, , Italy

IRCCS Azienda Ospedaliera Universitaria San Martino IST - Clinica Psichiatrica

Genova, , Italy

Azienda Ospedaliera Universitaria Pisana - Psichiatria 1

Pisa, , Italy

Azienda Ospedaliera Sant'Andrea - Dip. Di Neuroscienze, Salute mentale e Organi di senso- NESMOS

Roma, , Italy

Azienda Ospedaliera Universitaria Senese - Dip. Interaziendale di salute mentale - Psichiatria

Siena, , Italy

Countries

Italy

Related Links

http://www.angelinipharma.com

Sponsor website

Other Identifiers

2016-001714-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

136PO15274

Identifier Type: -

Identifier Source: org_study_id