Pilot Study of Duloxetine in Adult Attention Deficit Hyperactivity Disorder(ADHD)

NCT ID: NCT00940693

Last Updated: 2010-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-12-31

Brief Summary

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The purpose of this study is to determine whether duloxetine is an effective treatment of attention deficit disorder in adults.

Detailed Description

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Conditions

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Attention Deficit Disorder With Hyperactivity

Keywords

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Attention Deficit Disorder with Hyperactivity Duloxetine Adult ADDH ADHD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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duloxetine

Group Type ACTIVE_COMPARATOR

duloxetine

Intervention Type DRUG

60 mg capsule once per day for 6 weeks

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

one capsule of placebo taken one a day for 6 weeks

Interventions

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duloxetine

60 mg capsule once per day for 6 weeks

Intervention Type DRUG

placebo

one capsule of placebo taken one a day for 6 weeks

Intervention Type DRUG

Other Intervention Names

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cymbalta

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of ADHD of at least moderate intensity
* Able to give consent
* Able to swallow capsules

Exclusion Criteria

* Allergic or do not tolerate duloxetine
* Under psychotherapy for ADHD
* Taking a medication that interacts with duloxetine, including all psychotropic medication
* Treated with medication for ADHD
* Unstable medical condition
* Severe renal insufficiency
* Liver insufficiency
* Substance/alcool abuse or dependency in the last 6 months
* Pregnancy, nursing or inadequate contraceptive methods
* Suicide or homicide risk
* Organic brain syndrome
* Any diagnosis of lifetime bipolar disorder or psychotic disorder, and any actual diagnosis of anxious disorder or major depressive disorder
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role collaborator

Université de Montréal

OTHER

Sponsor Role lead

Responsible Party

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Centre Hospitalier Universitaire de Montréal

Principal Investigators

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Valérie Tourjman, MD

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier de l'Université de Montréal (CHUM)

Locations

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Centre Hospitalier Universitaire de Montréal: Hôpital Notre-Dame

Montreal, Quebec, Canada

Site Status

Countries

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Canada

References

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Tourjman SV, Bilodeau M. Improvement with duloxetine in an adult ADHD patient. J Atten Disord. 2009 Jul;13(1):95-6. doi: 10.1177/1087054708326109. Epub 2009 Apr 9.

Reference Type BACKGROUND
PMID: 19359667 (View on PubMed)

Other Identifiers

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09.008

Identifier Type: -

Identifier Source: org_study_id