Effect of Methylphenidate on Connectivity

Iris Sommer

Status and phase: Withdrawn; Phase 4

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Other: Placebo; Drug: Methylphenidate

Study type: Interventional

Funder types: Other

Identifiers

NCT01764672

NL42603.041.12 (Registry Identifier)

2012-005339-95

Details and patient eligibility

About

The goal of the study is to use graph theory to examine how the organization of the functional brain network may be altered by the administration of methylphenidate. This effect is to be compared between methylphenidate intake and placebo intake, as well as between healthy adult males and adult males with a diagnosis of Attention Deficit Hyperactivity Disorder.

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male sex
• Written informed consent
• For the Attention Deficit Hyperactivity Disorder group only: a diagnosis of Attention Deficit Hyperactivity Disorder

Exclusion criteria

• Age under 18 or > 40
• Previous or current medical, psychiatric, or neurological problems (with exception of Attention Deficit Hyperactivity Disorder group)
• Use of psychotropic medication
• Use of recreational drugs in the two weeks before start of the study
• Consuming an equivalent of > 5 cups of coffee per day
• Consuming three or more alcohol units per day
• The presence of one or more of the contraindications or warnings against the study drug as listed in the Summary of Product Characteristic
• Presence of any contraindication to Magnetic Resonance Imaging scanning (e.g. implanted metallic object or electronic device)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

Attention Deficit Hyperactivity Disorder

Experimental group

Description:

Adult males with Attention Deficit Hyperactivity disorder will participate in a crossover design and receive both methylphenidate and placebo on two separate days.

Treatment:

Drug: Methylphenidate

Other: Placebo

Healthy adults

Experimental group

Description:

Healthy male adults will participate in a crossover design and receive both methylphenidate and placebo on two separate days.

Treatment:

Drug: Methylphenidate

Other: Placebo