acute mania and hypomania (ICD-10: F30.0, F30.1, F31.0, F31.1) MedDRA version: 18.1 Level: LLT Classification code 10000852 Term: Acute mania System Organ Class: 100000004873
Conditions
Interventions
Trade Name: Medikinet 5 mg
Product Name: Methylphenidate
Pharmaceutical Form: Tablet
INN or Proposed INN: METHYLPHENIDATE
CAS Number: 113-45-1
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
University of Leipzig
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis: Current manic episode according to ICD-10 classification: F30.0, F30.1, F31.0 or F31.1. A previous diagnosis of schizo-affective disorder is NOT an exclusion criterion 2. Male or female >18 years of age 3. YMRS total score = 20 and = 45 points Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 78 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Any other current major psychiatric ICD-10 disorder (except follow: F40-48 Neurotic, stress-related and somatoform disorders, F50-F59 Behavioural syndromes associated with physiological disturbances and physical factors, F60-F69 Disorders of adult personality and behaviour) 2. Contraindications for treatment with methylphenidate except as noted otherwise. 3. Serious non-psychiatric disease (e.g. infectious, autoimmune or metabolic), that may interfere with the objectives of the study or with the safety or compliance of the subject, as judged by the investigator 4. Stable treatment with mood stabilisers including lithium, anticonvulsants (e.g. valproate, carbamazepine) or antipsychotics (e.g. risperidone, olanzapine) or benzodiazepines is NOT an exclusion criterion and will be continued; however, patients receiving more than 2 of this substances are NOT eligible for inclusion 5. Medical history of other disorders of CNS including tics or dyskinesia, 6. Medical history of cardiovascular diseases, moderate to severe hypertension, glaucoma, hyperfunction of the thyroid 7. Patients with congenital or acquired long QT syndrome, or with a familiy history of QT prolongation or other significant inherited cardiac disorders (e.g. family history of hypertrophic cardiomyopathy). 8. History of Electroconvulsive therapy within the last 3 month 9. Known alcohol and drug addiction or abuse, except for patients with abstinence > 3 month. Patients with sporadic abuse of cannabis (products) will not be excluded from the study. That is even true with a positive THC screen in urine. 10. Pregnant or breast-feeding 11. Concomitant participation in other clinical trials or participation during the 30 days prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the hypothesis that methylphenidate immediate release given twice daily (BID) is significantly superior to placebo in the treatment of manic symptoms in patients with bipolar disorder after 2.5 days of treatment as assessed by the Young Mania Rating Scale (YMRS).;Secondary Objective: 1. Methylphenidate immediate release is significantly superior to placebo in treatment of manic symptoms after 2 hours as assessed by the YMRS and PANSS 2. Change from baseline to endpoint (after 2.5 days of treatment) on the CGI-BP and PANSS-EC 3. 2.5 days of treatment with methylphenidate but not with placebo stabilise vigilance regulation as assessed by the ‘Vigilance Algorithm Leipzig’ (VIGALL) 4. Instability of vigilance regulation predicts response to methylphenidate 5. Methylphenidate immediate release given BID is associated with significantly less movements over the study period than placebo as assessed by actigraphy 6. Methylphenidate is significantly superior to placebo in improving sustained attention as assessed by the “Continuous Performance Test” (CPT) 7. Methylphenidate is significantly superior to placebo in improving cognitive performance as assessed by the “Screen for Cognitive Impairment in Psychiatry” (SCIP) ;Primary end point(s): After 2,5 days of treatment to test whether methylphenidate immediate release given twice daily (BID) is significantly superior to placebo in the treatment of manic symptoms in patients with bipolar disorder as assessed by YMRS.;Timepoint(s) of evaluation of this end point: After 2,5 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Methylphenidate immediate release given BID is significantly superior to placebo in the treatment of manic symptoms in patients with bipolar disorder after 2 hours of treatment as assessed by the YMRS and PANSS - Change from baseline to endpoint (after 2.5 days of treatment) on the CGI-BP and PANSS-EC - 2.5 days of treatment with methylphenidate but not with placebo stabilise vigilance regulation as assessed by the ‘Vigilance Algorithm Leipzig’ (VIGALL) - Instability of vigilance regulation as assessed by the VIGALL predicts response to methylphenidate - Methylphenidate immediate release given BID is associated with significantly less movements over the study period than placebo as assessed by actigraphy - Methylphenidate is significantly superior to placebo in improving sustained attention as assessed by the “Continuous Performance Test” (CPT) - Methylphenidate is significantly superior to placebo in improving cognitive performance as assessed by the “Screen for Cognitive Impairment in Psychiatry” (SCIP) ;Timepoint(s) of evaluation of this end point: After 2 hours respectively after 2,5 days. | — |
Countries
Belgium, Germany, Hungary, Spain
Contacts
Public ContactDr Michael Kluge
Department of Psychiatry of University of Leipzig
Outcome results
None listed