Quetiapine: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Quetiapine appears in the FDA drug-label database. Marketed as Quetiapine.
- Boxed warning
- The FDA label for Quetiapine carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
& USAGE Quetiapine is an atypical antipsychotic indicated for the treatment of: Schizophrenia ( 1.1 ) Bipolar I disorder manic episodes ( 1.2 ) Bipolar disorder, depressive episodes ( 1.2 ) 1.1 Schizophrenia Quetiapine is indicated for the treatment of schizophrenia. The efficacy of quetiapine in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). The effectiveness of quetiapine for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [ see Clinical Studies (14.1) ]. 1.2 Bipolar Disorder Quetiapine is indicated for the acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. Efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [ see Clinical Studies (14.2) ]. Quetiapine is indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. Efficacy was established in two 8-week monotherapy trials in adult patients wi…
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets. — The Harvard Drug Group | Class III (FDA: unlikely to cause harm) | Terminated | 2020-02-27 |
| Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets. — The Harvard Drug Group | Class III (FDA: unlikely to cause harm) | Terminated | 2020-02-27 |
| Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets. — The Harvard Drug Group | Class III (FDA: unlikely to cause harm) | Terminated | 2020-02-27 |
| Presence of Foreign Substance; metal shard found in tablet — Ascend Laboratories LLC | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2018-11-14 |
| Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets. — The Harvard Drug Group | Class III (FDA: unlikely to cause harm) | Terminated | 2020-02-27 |
Phase breakdown
Conditions being studied
Recruiting trials involving Quetiapine
- Bariatric Surgery and Pharmacokinetics of Quetiapine
- Comparing Antipsychotic Medications in LBD Over Time
- Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure
- Pimavanserin vs. Quetiapine for Treatment of Parkinson's Psychosis
- The Effect of a Six Week Intensified Pharmacological Treatment for Bipolar Depression Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.
Common questions
Is Quetiapine FDA-approved?
Yes, marketed as Quetiapine. Its FDA label carries a boxed warning.
How many recruiting trials involve Quetiapine?
5 recruiting trials across 11 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.