Clinical trial NCT01541605: Methylphenidate for the Treatment of Acute Mania
Official title: International Randomised Double-blind Placebo-controlled Study on the Initial Treatment of Acute Mania With Methylphenidate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mania
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: Spanish Clinical Research Network - SCReN
First posted: 2012-03-01
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims at evaluating the efficacy and safety of methylphenidate in the initial treatment of acute mania in patients with bipolar affective disorders.

Detailed description: Mania can be regarded as an autoregulatory mechanism to enhance unstable vigilance. There is increasing evidence that psychostimulants that increase vigilance may be effective in treating mania. However, controlled studies are lacking.

This is a two-arm, randomised, placebo-controlled, double-blind, parallel, multi-centre phase IIIb exploratory study to evaluate the efficacy and safety of methylphenidate in the initial treatment of acute mania in patients with bipolar affective disorders.

Eligibility criteria: Inclusion Criteria:

1. Inpatients
2. Written informed consent by patients who are competent to consent to study participation.
3. Diagnosis: manic episode according to the International Classification of Diseases 10th Revision (ICD-10): F30.0, F30.1, F31.0 or F31.1
4. Male or female of at least 18 years of age
5. YMRS total score ≥ 20 and ≤ 45 points
6. Body mass index (BMI) \> 17
7. Patients must be able to swallow tablets (study drug).

Exclusion Criteria:

1. Any other current major psychiatric ICD-10 disorder is an exclusion criterion except for the following F90, F17.1, F17.2, F40-F59, F60-F69
2. Contraindications for treatment with methylphenidate except as noted otherwise
3. Serious non-psychiatric disease, that may interfere with the objectives of the study or with the safety or compliance of the subject, as judged by the investigator
4. Oral administration of monoaminooxidase (MAO)-inhibitors within two weeks, fluoxetine within 6 weeks and of any other antidepressant or primarily psychotropic substance except for those specified below within one week before study entry.
5. 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 these substances are NOT eligible for inclusion
6. Medical history of other disorders of CNS including tics or dyskinesia
7. Medical history of cardiovascular diseases, severe hypertension, glaucoma, hyperfunction of the thyroid
8. Patients with congenital or acquired long QT syndrome, or with a familiy history of QT prolongation, sudden cardiac death or other significant inherited cardiac disorders (e.g. family history of hypertrophic cardiomyopathy).
9. History of Electroconvulsive therapy within the last 3 month
10. 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 Tetrahydrocannabinol (THC) screen in urine.
11. Pregnant or nursing woman
12. Concomitant participation in other clinical trials or participation during the 30 days prior to screening
13. Prior participation in this study
14. Suicidality

Primary outcomes:
measure: manic symptoms as assessed by the Young Mania Rating Scale (YMRS)
timeFrame: after 2.5 days of treatment
Secondary outcomes:
measure: EEG-vigilance as assessed by the Vigilanz Algorhithm Leipzig (VIGALL)
timeFrame: after 2.5 days of treatment
measure: movements as assessed by actimetry
timeFrame: after 2.5 days of treatment
measure: cognitive performance as assesd with the Screen for Cognitive Impairment in Psychiatry (SCIP)
timeFrame: after 2.5 days of treatment
Other outcomes:
Locations:
city: Kortenberg
country: Belgium
facility: Katholieke Universiteit Leuven, campus Kortenberg
city: Bochum
country: Germany
facility: Universität Bochum
city: Dresden
country: Germany
facility: Universität Dresden
city: Halle
country: Germany
facility: Universität Halle
city: Leipzig
country: Germany
facility: Universität Leipzig
city: Budapest
country: Hungary
facility: Semmelweis University
city: Barcelona
country: Spain
facility: Hospital Sant Pau
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Madrid
country: Spain
facility: Hospital Universitario la Princesa
city: Vitoria
country: Spain
facility: Hospital Santiago Apóstol
Study officials:
affiliation: University of Leipzig
name: Ulrich Hegerl, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kluge M, Hegerl U, Sander C, Dietzel J, Mergl R, Bitter I, Demyttenaere K, Gusmao R, Gonzalez-Pinto A, Perez-Sola V, Vieta E, Juckel G, Zimmermann US, Bauer M, Sienaert P, Quintao S, Edel MA, Bolyos C, Ayuso-Mateos JL, Lopez-Garcia P. Methylphenidate in mania project (MEMAP): study protocol of an international randomised double-blind placebo-controlled study on the initial treatment of acute mania with methylphenidate. BMC Psychiatry. 2013 Feb 27;13:71. doi: 10.1186/1471-244X-13-71.
citation: Hegerl U, Mergl R, Sander C, Dietzel J, Bitter I, Demyttenaere K, Gusmao R, Gonzalez-Pinto A, Zorrilla I, Alocen AG, Sola VP, Vieta E, Juckel G, Zimmermann US, Bauer M, Sienaert P, Quintao S, Edel MA, Bolyos C, Ayuso-Mateos JL, Lopez-Garcia P, Kluge M. A multi-centre, randomised, double-blind, placebo-controlled clinical trial of methylphenidate in the initial treatment of acute mania (MEMAP study). Eur Neuropsychopharmacol. 2018 Jan;28(1):185-194. doi: 10.1016/j.euroneuro.2017.11.003. Epub 2017 Nov 23.