BDNCT02020200
The Effect of Methylphenidate on Cognitive Abilities of Adults With Bipolar Disorder
A study testing MPH in people with BD, run by Shalvata Mental Health Center at 1 site in Israel.
Trial summary
The purpose of the study is to explore the effect of MPH on working memory, attention and decision making in adults with BD in remission or in depressed state. The results will be compared to findings in healthy adults and adults with ADHD. Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- BD
- What is being tested?
- MPH
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2014to Dec 2014
- Phase
- Interventional
- 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 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Hebrew Speakers
- Age 21-50
- Diagnosis of BD I or II (296.7 and 296.89 classifications in the DSM-IV-TR), according to medical records. Diagnosis will be confirmed by a psychiatrist during screening process using the Structured Clinical Interview for DSM-IV-TR (SCID).
Who cannot join
- Diagnosis of a clinical disorder other than BD or ADD/ADHD which may impair performance on tasks used in the study.
- BD patients diagnosed with an acute manic episode at screening, as established by YMRS>8. It will also be required that 3 months have elapsed since the latest manic state, according to the patients' history.
- Participants for whom there exists a contra-indication for consuming Ritalin.
- Pregnancy or current breastfeeding; Female participants will be asked to report whether they are pregnant or currently nursing and if so, they will be excluded from the study.
- Drug use in the previous 6 weeks according to participants' self report
- Electroconvulsive therapy (ECT) in the previous 6 months
Trial locations and contacts
1 site in 1 country.
Yechiel Levkovitz, MD, PhD contact
About this study
Official title: A Crossover Study on the Effect of Methylphenidate (MPH) on Cognitive Abilities of Adults With Bipolar Disorder (BD), During Remission or Depressed State, Compared With Healthy Adults and Adults With Attention Deficit Hyperactivity Disorder (ADHD).
The purpose of the study is to explore the effect of MPH on working memory, attention and decision making in adults with BD in remission or in depressed state. The results will be compared to findings in healthy adults and adults with ADHD. The investigators hypothesize that MPH will incur improved performance in all measures.
Read the detailed description
Following a detailed explanation about the trial and after obtaining informed consent from candidates, subjects will be asked to arrive at the cognitive laboratory at Shalvata MHC twice. Visits will include performance of computerized cognitive and decision making tasks, as well as two creativity tasks after the consumption of MPH or placebo.
- Conditions
- BD
- Being tested
- MPH, Placebo
- Keywords
- Bipolar Disorder, Methylphenidate, Cognitive Function
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPHDrug
Also called Ritalin
MPH dosage will be determined according to participants' body weight: dosage: 10 mg in case weight<40 kg; 30 mg in case weight>90 kg; otherwise 20 mg.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| MPH or Placebo | Experimental | MPH dosage will be determined according to participants' body weight: dosage: 10 mg in case weight<40 kg; 30 mg in case weight>90 kg; otherwise 20 mg. Both participants and investigators will be blinded to when participant receives MPH or Placebo. Receives: Drug: MPH; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function.
Cognitive function will be measured by scores on several computerized neuro-psychological and decision making tasks: digit-span task, spatial working memory task, raven's progressive matrices, test of variable attention and the Iowa gambling task.
Measured: Within 4 hours of intervention.
Secondary outcomes (1)
Creativity abilities.
Creativity will be measured by scores on two tests: the alternative use task and two subsets of the Torrance tests for creative thinking.
Measured: Within 4 hours of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BDStudies 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 N/A
- Primary purpose
- Diagnosis
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shalvata Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yechiel Levkovitz, MD, PhD, Principal investigator, Shalavata MHC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020200
- Sponsor's protocol ID
- 0021-12-SHA
- Status last verified
- Dec 2013
- First submitted
- 14 Dec 2013
- Last updated
- 24 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Crossover Study on the Effect of Methylphenidate (MPH) on Cognitive Abilities of Adults With Bipolar Disorder (BD), During Remission or Depressed State, Compared With Healthy Adults and Adults With Attention Deficit Hyperactivity Disorder (ADHD).
- ClinicalTrials.gov ID
- NCT02020200
- Acronym / sponsor ID
- 0021-12-SHA
- Conditions
- BD
- Keywords
- Bipolar Disorder, Methylphenidate, Cognitive Function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (estimated)
- First posted
- 24 Dec 2013 (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.
The purpose of the study is to explore the effect of MPH on working memory, attention and decision making in adults with BD in remission or in depressed state. The results will be compared to findings in healthy adults and adults with ADHD. The investigators hypothesize that MPH will incur improved performance in all measures.
Detailed description
Following a detailed explanation about the trial and after obtaining informed consent from candidates, subjects will be asked to arrive at the cognitive laboratory at Shalvata MHC twice. Visits will include performance of computerized cognitive and decision making tasks, as well as two creativity tasks after the consumption of MPH or placebo.
Study design
- Primary purpose
- Diagnosis
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MPH or Placebo | Experimental | Drug: MPH, Drug: PlaceboMPH dosage will be determined according to participants' body weight: dosage: 10 mg in case weight<40 kg; 30 mg in case weight>90 kg; otherwise 20 mg. Both participants and investigators will be blinded to when participant receives MPH or Placebo. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Hebrew Speakers
- Age 21-50
- Diagnosis of BD I or II (296.7 and 296.89 classifications in the DSM-IV-TR), according to medical records. Diagnosis will be confirmed by a psychiatrist during screening process using the Structured Clinical Interview for DSM-IV-TR (SCID).
Key exclusion criteria (6 listed)
- Diagnosis of a clinical disorder other than BD or ADD/ADHD which may impair performance on tasks used in the study.
- BD patients diagnosed with an acute manic episode at screening, as established by YMRS>8. It will also be required that 3 months have elapsed since the latest manic state, according to the patients' history.
- Participants for whom there exists a contra-indication for consuming Ritalin.
- Pregnancy or current breastfeeding; Female participants will be asked to report whether they are pregnant or currently nursing and if so, they will be excluded from the study.
- Drug use in the previous 6 weeks according to participants' self report
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 |
|---|---|---|
| MPHAlso: RitalinMPH dosage will be determined according to participants' body weight: dosage: 10 mg in case weight<40 kg; 30 mg in case weight>90 kg; otherwise 20 mg. | Drug | MPH or Placebo |
| Placebo | Drug | MPH or Placebo |
Primary outcome
Cognitive function.
Time frame: Within 4 hours of intervention.
Cognitive function will be measured by scores on several computerized neuro-psychological and decision making tasks: digit-span task, spatial working memory task, raven's progressive matrices, test of variable attention and the Iowa gambling task.
1 secondary outcome
Creativity abilities.
Time frame: Within 4 hours of intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2013.
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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.
Yechiel Levkovitz, MD, PhD contact
Yechiel Levkovitz, MD, PhD principal investigator
Shalavata MHC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MPH in people with BD, run by Shalvata Mental Health Center at 1 site in Israel.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 24 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yael Lewis, MD (+97297478644, yaelle4@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function. (time frame: Within 4 hours of intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Dec 2013.