Overview

Methylphenidate for the Treatment of Acute Mania

Status:
Completed

Trial end date:
2016-05-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Michael Kluge

Collaborators:

Spanish Clinical Research Network - CAIBER
Spanish Clinical Research Network - SCReN

Treatments:

Methylphenidate

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