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

NCT03210480 | Terminated Phase 4

• 2 other identifiers: 136PO152742016-001714-14
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 6

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®).

Conditions

Bipolar Disorder

Keywords

Lithium Sulphate; Prolonged release formulation; Lithium carbonate; Immediate release formulation; Bipolar Disorder; Tremor

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline - Week 1

Secondary Outcomes (8)

• Change of item 2.5 (tremor) in Udvalg for Kliniske Undersøgelser (UKU) scale

  Baseline - Weeks 4 and 12

• Change of item 3.8 in Udvalg for Kliniske Undersøgelser (UKU) scale

  Baseline - Weeks 1, 4 and 12

• Change in Montgomery-Asberg Depression Rating Scale (MADRS)

  Baseline - Weeks 1, 4 and 12

• Change in Young Mania Rating Scale (YMRS)

  Baseline - Weeks 1, 4 and 12

• Change in Treatment Satisfaction Questionnaire for Medication (TSQM) scale

  Baseline - Weeks 1 and 12

Study Arms (2)

Group 1

EXPERIMENTAL

Lithium sulphate prolonged-release 660 mg

Drug: Lithium sulphate prolonged-release 660 mg

Group 2

ACTIVE COMPARATOR

Lithium carbonate immediate-release 150 mg and 300 mg

Drug: Lithium carbonate immediate-release 150 mg and 300 mg

Interventions

Lithium sulphate prolonged-release 660 mg 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.

Also known as: LITHIOFOR®

Group 1

Lithium carbonate immediate-release 150 mg and 300 mg 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.

Also known as: CARBOLITHIUM®

Group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Aziende Chimiche Riunite Angelini Francesco S.p.A: lead
• Mediolanum Cardio Research: collaborator

Study Sites (6)

Ospedale San Giovanni di Dio di Orbetello Unità Funzionale Salute Mentale

Orbetello, Grosseto, 58016, Italy

Location

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

Bergamo, 24127, Italy

Location

IRCCS Azienda Ospedaliera Universitaria San Martino IST - Clinica Psichiatrica

Genova, 16132, Italy

Location

Azienda Ospedaliera Universitaria Pisana - Psichiatria 1

Pisa, 56126, Italy

Location

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

Roma, 00189, Italy

Location

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

Siena, 53100, Italy

Location

Related Links

• Sponsor website

MeSH Terms

Conditions

Bipolar Disorder; Tremor

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, multicenter, prospective study.

Study Record Dates

• First Submitted: June 23, 2017
• First Posted: July 7, 2017
• Study Start: March 28, 2017
• Primary Completion: September 20, 2019
• Study Completion: September 20, 2019
• Last Updated: January 10, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (6)