NCT00363298

Brief Summary

The study hypothesis is that dextro-amphetamine (d-amphetamine) will be safe and effective when used to augment treatment for Obsessive-Compulsive Disorder (OCD), and that tolerance (loss of therapeutic effect) to the medication will not develop over a period of several weeks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2006

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 15, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
9.1 years until next milestone

Results Posted

Study results publicly available

March 28, 2017

Completed
Last Updated

March 28, 2017

Status Verified

February 1, 2017

Enrollment Period

1.6 years

First QC Date

August 9, 2006

Results QC Date

April 20, 2015

Last Update Submit

February 7, 2017

Conditions

Obsessive-Compulsive Disorder

Keywords

D-amphetamine, dextro-amphetamine, stimulant drug

Outcome Measures

Primary Outcomes (2)

  • Number of Subjects With Clinical Global Impressions Scale - Improvement (CGI-I) Score of 1 or 2

    Clinical Global Impressions Scale Improvement Score = 1 (very much improved), or 2 (much improved). Additional possible scale scores are 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) and 7 (very much worse).

    At end of week 5, except 1 d-amphetamine subject rated at end of week 2

  • Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) Score

    Yale-Brown Obsessive-Compulsive Scale score by blinded investigator in direct interview. The scale score is the sum of ten items (5 for obsessions and 5 for compulsions: time occupied, degree of interference with functioning, degree of distress, effort to resist the symptom, success in resisting), each rated from 0 to 4, with higher scores indicating more severe OCD. Maximum score is 40. Scores of 14 and below are often described as "subclinical," though patients with these scores may still exhibit troubling symptoms and mild to moderate distress. A total score of 8 or less is often termed "remission." A decrease in total score from baseline to endpoint of either 25% or 35% is often used as a "responder" criterion in clinical trials.

    At end of week 5, except 1 d-amphetamine subject rated at end of week 2

Study Arms (2)

d-amphetamine

EXPERIMENTAL

dextro-amphetamine capsules, 15 mg per capsule, in Bottles A and B, dose: one from Bottle A each morning and 1 from Bottle B each morning

Drug: dextro-amphetamine

Sham comparison

SHAM COMPARATOR

caffeine in capsules identical to those containing d-amphetamine, with 200 mg of caffeine in Bottle A capsules, and 100 mg of caffeine in Bottle B capsules, dose was 1 capsule from Bottle A and 1 capsule from Bottle B each morning

Drug: Sham Comparison

Interventions

dextro-amphetamineDRUG

dextro-amphetamine dosage form: 15 mg capsules, in Bottles A and B. Dosage: One capsule from Bottle A and one capsule from bottle B each morning. Frequency: once daily. Duration: 5 weeks.

Also known as: Dexedrine
d-amphetamine
Sham ComparisonDRUG

caffeine dosage form: capsules identical to those in dextro-amphetamine arm, but containing 200 mg caffeine in Bottle A and 100 mg caffeine in Bottle B. Frequency: once daily. Duration: 5 weeks

Also known as: Caffeine, 300 mg/day
Sham comparison

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • outpatient age 18 through 55 inclusive
  • meets DSM-IV criteria for obsessive-compulsive disorder (OCD) with Yale-Brown Obsessive-Compulsive Scale (YBOCS) score greater than or equal to 20
  • provides written informed consent
  • has taken for at least 12 weeks at least the dose shown of a selective serotonin reuptake inhibitor (SSRI) \[citalopram, escitalopram, or fluoxetine 20 mg/d; paroxetine 40 mg/d; sertraline 50 mg/d\]; or venlafaxine 225 mg/d; or duloxetine 60 mg/d.
  • if taking buspar, gabapentin, an atypical antipsychotic, or a benzodiazepine, dose has been stable for 4 weeks
  • has negative urine drug and pregnancy tests
  • is practicing reliable birth control method
  • has blood pressure readings at screening visit that are less than 140 mm Hg systolic and 90 mm Hg diastolic,
  • weight is greater than 100 lbs at screen

You may not qualify if:

  • requires psychotropic medications other than an Serotonin Reuptake Inhibitor (SRI), a benzodiazepine, buspirone, an atypical antipsychotic, and/or gabapentin
  • is taking clomipramine
  • is taking fluvoxamine
  • is taking medication that inhibits hepatic enzyme CYP1A2
  • is taking a monoamine oxidase inhibitor
  • has co-morbid tics or Tourette's disorder
  • has hoarding as the primary or only OCD symptom
  • has a history of panic disorder
  • has a history of glaucoma
  • has a history of seizures
  • has a history of schizophrenia or psychotic disorder, or schizotypal personality disorder
  • has depression with current suicide risk
  • has mental retardation, pervasive developmental disorder, or cognitive disorder
  • has a factitious disorder
  • has current or past cyclothymic disorder or bipolar disorder
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

  • Koran LM, Aboujaoude E, Gamel NN. Double-blind study of dextroamphetamine versus caffeine augmentation for treatment-resistant obsessive-compulsive disorder. J Clin Psychiatry. 2009 Nov;70(11):1530-5. doi: 10.4088/JCP.08m04605. Epub 2009 Jun 30.

    PMID: 19573497RESULT

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

DextroamphetamineCaffeine

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AmphetamineAmphetaminesPhenethylaminesEthylaminesAminesOrganic ChemicalsXanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Limitations and Caveats

Modest sample size of 24 subjects, 12 in each drug group. Observation period was only 5 weeks long.

Results Point of Contact

Title
Lorrin M. Koran, M.D.
Organization
Stanford University Medical Center, Department of Psychiatry
lkoran@stanford.edu
650 498-5035

Study Officials

  • Lorrin M Koran

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry, Emeritus

Study Record Dates

First Submitted

August 9, 2006

First Posted

August 15, 2006

Study Start

August 1, 2006

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

March 28, 2017

Results First Posted

March 28, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)