ManiaPhase 3NCT01541605
Methylphenidate for the Treatment of Acute Mania
A Phase 3 study testing methylphenidate in people with Mania, run by Michael Kluge at 10 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mania
- What is being tested?
- methylphenidate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 10 sitesin 4 countries
- Study dates
- Mar 2012to May 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatients
- Written informed consent by patients who are competent to consent to study participation.
- Diagnosis: manic episode according to the International Classification of Diseases 10th Revision (ICD-10): F30.0, F30.1, F31.0 or F31.1
- Male or female of at least 18 years of age
- YMRS total score ≥ 20 and ≤ 45 points
- Body mass index (BMI) > 17
- Patients must be able to swallow tablets (study drug).
Who cannot join
- 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
- Contraindications for treatment with methylphenidate except as noted otherwise
- 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
- 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.
- 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
- Medical history of other disorders of CNS including tics or dyskinesia
Show all 14Show fewer
- Medical history of cardiovascular diseases, severe hypertension, glaucoma, hyperfunction of the thyroid
- 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).
- History of Electroconvulsive therapy within the last 3 month
- 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.
- Pregnant or nursing woman
- Concomitant participation in other clinical trials or participation during the 30 days prior to screening
- Prior participation in this study
- Suicidality
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
Germany4 sites
Universität Bochum
Bochum, 44791
Universität Dresden
Dresden, 01307
Universität Halle
Halle
Universität Leipzig
Leipzig
Spain4 sites
Hospital Sant Pau
Barcelona, 8025
Hospital Clinic
Barcelona, 8036
Hospital Universitario la Princesa
Madrid, 28006
Hospital Santiago Apóstol
Vitoria-Gasteiz, 01004
Belgium1 site
Katholieke Universiteit Leuven, campus Kortenberg
Kortenberg, 3070
About this study
Official title: International Randomised Double-blind Placebo-controlled Study on the Initial Treatment of Acute Mania With Methylphenidate
This study aims at evaluating the efficacy and safety of methylphenidate in the initial treatment of acute mania in patients with bipolar affective disorders.
Read the 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.
- Conditions
- Mania
- Being tested
- methylphenidate, Placebo
- Medical subject headings
- Mania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylphenidateDrug
tablets for oral use
PlaceboDrug
tablets for oral use
| Study group | Role | What they receive |
|---|---|---|
| methylphenidate | Active comparator | Not described Receives: Drug: methylphenidate |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
manic symptoms as assessed by the Young Mania Rating Scale (YMRS)
Measured: after 2.5 days of treatment
Secondary outcomes (3)
EEG-vigilance as assessed by the Vigilanz Algorhithm Leipzig (VIGALL)
Measured: after 2.5 days of treatment
movements as assessed by actimetry
Measured: after 2.5 days of treatment
cognitive performance as assesd with the Screen for Cognitive Impairment in Psychiatry (SCIP)
Measured: after 2.5 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ManiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Kluge
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Clinical Research Network - SCReN
- Responsible party
- Sponsor-investigator, Michael Kluge, University of Leipzig
- Investigators
- Ulrich Hegerl, Prof. Dr., Principal investigator, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01541605
- Sponsor's protocol ID
- MEMAP1
- Status last verified
- Jun 2016
- First submitted
- 16 Feb 2012
- Last updated
- 10 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23446109Hegerl 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.
PubMed 29174864
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Randomised Double-blind Placebo-controlled Study on the Initial Treatment of Acute Mania With Methylphenidate
- ClinicalTrials.gov ID
- NCT01541605
- Acronym / sponsor ID
- MEMAP1
- Conditions
- Mania
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Michael KlugeUniversity, hospital or other
- Collaborators
- Spanish Clinical Research Network - SCReN
- Study start
- Mar 2012
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 1 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| methylphenidate | Active comparator | Drug: methylphenidate |
| placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Inpatients
- Written informed consent by patients who are competent to consent to study participation.
- Diagnosis: manic episode according to the International Classification of Diseases 10th Revision (ICD-10): F30.0, F30.1, F31.0 or F31.1
- Male or female of at least 18 years of age
- YMRS total score ≥ 20 and ≤ 45 points
Key exclusion criteria (14 listed)
- 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
- Contraindications for treatment with methylphenidate except as noted otherwise
- 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
- 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.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| methylphenidatetablets for oral use | Drug | methylphenidate |
| Placebotablets for oral use | Drug | placebo |
Primary outcome
manic symptoms as assessed by the Young Mania Rating Scale (YMRS)
Time frame: after 2.5 days of treatment
3 secondary outcomes
EEG-vigilance as assessed by the Vigilanz Algorhithm Leipzig (VIGALL)
Time frame: after 2.5 days of treatment
movements as assessed by actimetry
Time frame: after 2.5 days of treatment
cognitive performance as assesd with the Screen for Cognitive Impairment in Psychiatry (SCIP)
Time frame: after 2.5 days of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2016.
- Background: PubMed 23446109Kluge 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.
- Derived from this study: PubMed 29174864Hegerl 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.
Related trials for Mania
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine
Mania, Bipolar Disorder
RecruitingPhase 3
A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
Bipolar Disorder Type I With Mania
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder
Bipolar-I Disorder With Mania or Mania With Mixed Features
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)
Bipolar Disorder Type I With Mania or Mania With Mixed Features
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrich Hegerl, Prof. Dr. principal investigator
University of Leipzig
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing methylphenidate in people with Mania, run by Michael Kluge at 10 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Spain, Belgium, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
manic symptoms as assessed by the Young Mania Rating Scale (YMRS) (time frame: after 2.5 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01541605, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2016.