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Tricyclic Antidepressant

Intravenous vs Oral Clomipramine for Obsessive-Compulsive Disorder

Phase 2

Waitlist Available

Research Sponsored by National Center for Research Resources (NCRR)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No hypersensitivity to or prior severe adverse experience with clomipramine, No medical contraindication to serotonin re-uptake inhibitors or tricyclic antidepressants

No prostatic hypertrophy, No narrow-angle glaucoma, i.e., intraocular pressure greater than 22 mm Hg, No uncontrolled hyperthyroidism, No other clinically significant abnormality, e.g.: Neurologic, Metabolic, Gastrointestinal, Autoimmune

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is looking at whether clomipramine works better when given intravenously or by mouth, in people with obsessive compulsive disorder.

Who is the study for?

This trial is for adults with Obsessive Compulsive Disorder (OCD) diagnosed for at least a year, who have tried at least two serotonin re-uptake inhibitor therapies without success. Participants must be literate, not at risk of suicide, and free from certain psychiatric and medical conditions. They should not be pregnant or nursing and must use contraception if fertile.Check my eligibility

What is being tested?

The study tests the effectiveness of clomipramine given intravenously versus orally in patients with OCD. After an initial 'pulse loading' dose to quickly raise drug levels in the body, participants will continue with maintenance therapy for 12 weeks to see which method is more effective.See study design

What are the potential side effects?

Clomipramine can cause side effects like dry mouth, constipation, blurred vision, dizziness upon standing up due to low blood pressure (orthostatic hypotension), sleepiness or trouble sleeping (insomnia), weight gain or loss, sexual dysfunction and increased heart rate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have no allergies or bad reactions to clomipramine or similar depression medications.

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I don't have prostate enlargement, high eye pressure, uncontrolled thyroid issues, or significant health problems.

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I have tried at least 2 different serotonin re-uptake inhibitors without success.

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I do not have heart problems or high blood pressure.

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My liver tests are normal or slightly elevated, with no liver disease.

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I do not have any kidney problems, like trouble urinating.

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I have been diagnosed with OCD for at least a year.

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I don't have anemia, leukopenia, bleeding disorders, or bone marrow issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Center for Research Resources (NCRR)Lead Sponsor

537 Previous Clinical Trials

316,940 Total Patients Enrolled

2 Trials studying Obsessive-Compulsive Disorder

290 Patients Enrolled for Obsessive-Compulsive Disorder

Stanford UniversityOTHER

2,386 Previous Clinical Trials

17,333,932 Total Patients Enrolled

15 Trials studying Obsessive-Compulsive Disorder

1,327 Patients Enrolled for Obsessive-Compulsive Disorder

Lorrin KoranStudy ChairStanford University

Media Library

Clomipramine (Tricyclic Antidepressant) Clinical Trial Eligibility Overview. Trial Name: NCT00004310 — Phase 2

Obsessive-Compulsive Disorder Research Study Groups:

Obsessive-Compulsive Disorder Clinical Trial 2023: Clomipramine Highlights & Side Effects. Trial Name: NCT00004310 — Phase 2

Clomipramine (Tricyclic Antidepressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00004310 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must potential participants fulfill in order to be eligible for this clinical experiment?

"This trial is recruiting 76 participants diagnosed with obsessive-compulsive disorder, aged between 18 and 55. Patients must meet the following criteria: they must have a primary diagnosis of OCD that has persisted for at least one year; display signs outlined in the DSM-IV according to structured clinical interview; score 20 or higher on YBOCS scale unless only experiencing obsessions/compulsions, as well as not suffering from any excluded diagnoses such as bipolar disorder or anorexia nervosa. Furthermore, patients need to have failed two prior regimens of serotonin reuptake inhibitors therapy within 3 months before joining this study, while also being free"

Answered by AI

Is enrollment open for this clinical trial?

"Clinicaltrials.gov's records suggest that this trial, which was first announced on October 1st 1999 and revised as recently as June 23rd 2005, is no longer seeking applicants at the present moment. However, there are 991 other clinical trials actively recruiting participants right now."

Answered by AI

Does this research endeavor accept participants that are over thirty years old?

"In order to be accepted into this trial, patients must range between 18-55 years of age. As an alternative, those aged under 18 have 256 trials available and people older than 65 can participate in 660 clinical studies."

Answered by AI