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CLOMIPRAMINE HYDROCHLORIDE
At a glance
| Generic name | CLOMIPRAMINE HYDROCHLORIDE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1989 |
Approved indications
Boxed warnings
- Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of clomipramine hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Clomipramine hydrochloride capsules, USP is not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD) ( see WARNINGS , Clinical Worsening and Suicide Risk; PRECAUTIONS , Information for Patients ; and PRECAUTIONS , Pediatric Use ).
Common side effects
- Somnolence
- Tremor
- Dizziness
- Headache
- Insomnia
- Libido change
- Nervousness
- Myoclonus
- Increased appetite
- Paresthesia
- Memory impairment
- Anxiety
Key clinical trials
- MODELING OBSESSIVE COMPULSIVE DISORDER AND EXPLORING TREATMENT RESPONSE USING INNOVATIVE THERAPIES AND STEM CELLS (NA)
- Reducing Maximal Support in OCD: Efficacy of Stepped-Care Online CBT (NA)
- Effect of a Family-Based CBT Self-Help Intervention for Adolescents With OCD (NA)
- Pharmaco(Epi)Genetic, Proteomic, and Microbiomic Study of Obsessive-Compulsive Disorder (NA)
- Combination Therapy of Different Antidepressants With Dietary Supplements (NA)
- Comparative Responses to 15 Different Antidepressants in Major Depressive Disorder
- Efficacy of Hydroxyzine for Patients With Panic Disorder (PHASE4)
- Taste Supra-thresholds Among a Sample of Depressed Egyptian Adult Under Anti-depressants Therapy
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- CLOMIPRAMINE HYDROCHLORIDE CI brief — competitive landscape report
- CLOMIPRAMINE HYDROCHLORIDE updates RSS · CI watch RSS