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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03210480
Recruitment Status : Terminated (Sponsor's decision due to slow enrollment rate.)
First Posted : July 7, 2017
Last Update Posted : January 10, 2020
Sponsor:
Collaborator:
Mediolanum Cardio Research
Information provided by (Responsible Party):
Aziende Chimiche Riunite Angelini Francesco S.p.A

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®).

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Lithium sulphate prolonged-release 660 mg Drug: Lithium carbonate immediate-release 150 mg and 300 mg Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open-label, multicenter, prospective study.
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : March 28, 2017
Actual Primary Completion Date : September 20, 2019
Actual Study Completion Date : September 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1
Lithium sulphate prolonged-release 660 mg
Drug: 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.
Other Name: LITHIOFOR®

Active Comparator: Group 2
Lithium carbonate immediate-release 150 mg and 300 mg
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.
Other Name: CARBOLITHIUM®




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change of item 2.5 (tremor) in Udvalg for Kliniske Undersøgelser (UKU) scale [ Time Frame: Baseline - Weeks 4 and 12 ]
    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.

  2. Change of item 3.8 in Udvalg for Kliniske Undersøgelser (UKU) scale [ Time Frame: Baseline - Weeks 1, 4 and 12 ]
    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.

  3. Change in Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Baseline - Weeks 1, 4 and 12 ]
    Change from baseline of total score in MADRS scale after 1-, 4- and 12-week treatment period.

  4. Change in Young Mania Rating Scale (YMRS) [ Time Frame: Baseline - Weeks 1, 4 and 12 ]
    Change from baseline of total score in YMRS scale after 1-, 4- and 12-week treatment period.

  5. Change in Treatment Satisfaction Questionnaire for Medication (TSQM) scale [ Time Frame: Baseline - Weeks 1 and 12 ]
    Change from baseline in each sub-scale of TSQM after 1- and 12-week treatment period.

  6. Change in Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) [ Time Frame: Baseline - Weeks 1 and 12 ]
    Change from baseline in Q-LES-Q-SF after 1- and 12-week treatment period.

  7. Change in Clinical Global Impression (CGI) scale [ Time Frame: Baseline - Weeks 1 and 12 ]
    Assessment by the physician of the overall efficacy by CGI scale after 1- and 12-week treatment period.

  8. Frequency of treatment-related adverse events [ Time Frame: 12 weeks ]
    Monitoring of the frequency of adverse events, physical examination, vital signs, ECG, laboratory analyses, plasma Lithium concentration.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210480


Locations
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Italy
Ospedale San Giovanni di Dio di Orbetello Unità Funzionale Salute Mentale
Orbetello, Grosseto, Italy, 58016
Azienda Ospedaliera Papa Giovanni XXIII - Servizio Psichiatrico di Diagnosi e Cura (SPDC 1)
Bergamo, Italy, 24127
IRCCS Azienda Ospedaliera Universitaria San Martino IST - Clinica Psichiatrica
Genova, Italy, 16132
Azienda Ospedaliera Universitaria Pisana - Psichiatria 1
Pisa, Italy, 56126
Azienda Ospedaliera Sant'Andrea - Dip. Di Neuroscienze, Salute mentale e Organi di senso- NESMOS
Roma, Italy, 00189
Azienda Ospedaliera Universitaria Senese - Dip. Interaziendale di salute mentale - Psichiatria
Siena, Italy, 53100
Sponsors and Collaborators
Aziende Chimiche Riunite Angelini Francesco S.p.A
Mediolanum Cardio Research
Additional Information:
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Responsible Party: Aziende Chimiche Riunite Angelini Francesco S.p.A
ClinicalTrials.gov Identifier: NCT03210480    
Other Study ID Numbers: 136PO15274
2016-001714-14 ( EudraCT Number )
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: January 10, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aziende Chimiche Riunite Angelini Francesco S.p.A:
Lithium Sulphate
Prolonged release formulation
Lithium carbonate
Immediate release formulation
Bipolar Disorder
Tremor
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Lithium Carbonate
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs