Open-Label Pilot Study to Examine the Value of Substituting Quetiapine for Benzodiazepines
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ClinicalTrials.gov Identifier: NCT01244711 |
Recruitment Status
:
Terminated
(Terminated: recruiting or enrolling participants has halted prematurely)
First Posted
: November 19, 2010
Results First Posted
: March 6, 2015
Last Update Posted
: April 3, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Major Depression Generalized Anxiety Disorder | Drug: quetiapine | Phase 4 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-label Pilot Study to Examine the Value of Substituting Quetiapine for Benzodiazepines in Treatment-refractory Patients With Unipolar Depression or Generalized Anxiety Disorder and Chronic Benzodiazepine Use |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | September 2011 |
Actual Study Completion Date : | September 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Quetiapine
Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.
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Drug: quetiapine
Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.
Other Name: Seroquel-XR
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- Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 12 weeks ]For MDD: The primary efficacy measures will be change from baseline to endpoint in the MADRS and the change in mean daily benzodiazepine dose in diazepam equivalents during the past week. Range is 0 (least severe) to 50 (most severe).

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
For inclusion in the study subjects must fulfil all of the following criteria:
- Provision of written informed consent
- A diagnosis of a current major depressive episode (n =20) or generalized anxiety disorder (n = 20) of at least 4 weeks duration, as defined by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV) and assessed on the SCID. Subjects may be included if they meet criteria for double depression, i.e., current major depression with antecedent dysthymic disorder, major depression in partial remission or bipolar depression. MDD subjects must have a 24 item Hamilton Depression Rating Scale Score (HAM-D) at intake >/= 20. GAD subjects must have a Hamilton Anxiety Rating Scale Score (HAM-A) at intake >/= 20. Patients who meet criteria for current GAD only during a current episode of MDD will be considered to have MDD, according to DSM-IV convention.
- Females and/or males aged 18-65 years
- Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment
- Able to understand and comply with the requirements of the study
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All subjects must report BZ use more days than not persistent for more than 6 months and a stable regimen of mood stabilizers and/or antidepressant medication for at least 8 weeks.
Exclusion Criteria:
-
Any of the following is regarded as a criterion for exclusion from the study:
- Pregnancy or lactation
- Any DSM-IV Axis I disorder not defined in the inclusion criteria
- Axis II diagnosis of antisocial, schizotypal or severe borderline personality disorder(defined as patients who are high risk for being unable to complete the study due to hospitalization, suicide attempts, significant self-mutilation, or other self-injurious or destructive behavior).
- Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
- Known intolerance or lack of response to quetiapine fumarate as judged by the investigator
- Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir
- Use of any of the following cytochrome P450 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids
- Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation
- Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
- Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment
- Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
- Unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by the investigator
- Involvement in the planning and conduct of the study
- Previous enrolment or randomisation of treatment in the present study.
- Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01244711
United States, New York | |
Weill Cornell Medical College | |
New York, New York, United States, 10065 |
Principal Investigator: | james h kocsis, md | weill cornell mc |
Responsible Party: | Weill Medical College of Cornell University |
ClinicalTrials.gov Identifier: | NCT01244711 History of Changes |
Other Study ID Numbers: |
IRUSQUET0483 |
First Posted: | November 19, 2010 Key Record Dates |
Results First Posted: | March 6, 2015 |
Last Update Posted: | April 3, 2015 |
Last Verified: | March 2015 |
Keywords provided by Weill Medical College of Cornell University:
Major Depression Generalized Anxiety Disorder Benzodiazepine Quetiapine |
Additional relevant MeSH terms:
Depression Depressive Disorder Anxiety Disorders Depressive Disorder, Major Behavioral Symptoms Mood Disorders Mental Disorders |
Quetiapine Fumarate Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs |