Resources for Clinicians
Medications not permitted
Participants must not be prescribed any of the active IMPs during the trial. This includes medications that are combined or include the IMPs as an ingredient.
In view of the double-blind nature of the trial, none of the medications listed in the table below may be prescribed to participants who were eligible for the associated arm, after randomisation in view of safety concerns associated with at least one of the possible active treatments. If any of these medications is deemed essential for the effective clinical care of a participant, they must discontinue IMP if they were eligible for the associated arm, but can remain in the trial for follow-up as per this protocol.
|
Medication |
Not permitted within these treatment arms: |
|
Monoamine oxidase inhibitor (MAOi) (e.g. Isocarboxazid, Phenelzine, Tranylcypromine, Selegiline, Rasagiline) |
Atomoxetine |
|
CYP2D6 inhibitor (e.g. Buproprion, Cinacalcet, Fluoxetine, Paroxetine, Terbinafine, Quinidine) |
Atomoxetine |
|
CYP2D6 inducers (e.g. Rifampicin, Corticosteroids such as Dexamethasone) |
Atomoxetine |
|
ADHD medications (e.g. Dexamfetamine, Lisdexamfetamine) |
Atomoxetine |
|
Ropeginterferon alfa |
Atomoxetine |
|
Berotralstat |
Atomoxetine |
|
Dacominitib |
Atomoxetine |
|
Elglustat |
Atomoxetine |
|
Givosiran |
Atomoxetine |
|
Panobinostat |
Atomoxetine |
|
Excessive Alcohol (investigator discretion) |
Atomoxetine and Metformin |
|
Insulin |
Metformin |
|
Diabetes medication (e.g. Sulphonylureas ( Gliclazide, Glipizide, Glimepiride, Tolbutamide); Alpha glucosidase inhibitors (Acarbose); Prandial glucose regulators (Repaglinide); Thiazolidinediones (Pioglitazone); GLP-1 agonists if used for diabetes (Exenatide, Semaglutide, Liraglutide); DPP-4 inhibitors (Sitagliptin, Linagliptin); SGLT2 inhibitors (Dapagliflozin, Canagliflozin, Empagliflozin) |
Metformin |
|
Iodinated contrast agents* |
Metformin |
Medications to be used with caution
The drugs listed in the table below have been found to interact unfavourably with the AD-SMART IMPs. As this is a blinded study, caution as determined by the clinical team and their clinical judgement must be used with the following medication:
|
Medication |
Caution due to |
|
Beta-2-Agonist (e.g. Salbutamol, Formoterol, Indacaterol, Olodaterol, Salmeterol, Terbutaline, Vilanterol) |
Atomoxetine |
|
Serotonergic drugs with minimal CYPD26 inhibitors (e.g. Selective serotonin re-uptake inhibitors (SSRIs) (Citalopram, Escitalopram, Sertraline); Serotonin norepinephrine re-uptake inhibitors (SNRIs) (Venlafaxine); Opiods (e.g. tramadol); Tetracycline or tricyclic antidepressants (Amitriptyline, Nortriptyline) |
Atomoxetine |
|
Pressor agents or drugs that may increase blood pressure |
Atomoxetine |
|
Medicinal products that can be associated with renal impairment (e.g.NSAIDs, including selective cyclooxygenase (COX) II inhibitors; ACE inhibitors; Angiotensin II receptor antagonists; Diuretics, especially loop diuretics) |
Metformin |
|
Medicinal products with intrinsic hyperglycaemic activity (e.g. Glucocorticoids (systemic and local routes), sympathomimetics) |
Metformin |
|
Inhibitors of Organic Cation Transporters (OCT) 1 (e.g. Verapamil) |
Metformin |
|
Inducers of OCT1 (e.g. Rifampicin) |
Metformin |
|
Inhibitors of OCT2 (e.g. Cimetidine, Dolutegravir, Ranolazine, Trimethoprim, Vandetanib, Isavuconazole) |
Metformin |
|
Inhibitors of both OCT1 and OCT2 (e.g. Crizotinib, Olaparib) |
Metformin |