Open-Label Pilot Study to Examine the Value of Substituting Quetiapine for Benzodiazepines

This study has been terminated.
(Terminated: recruiting or enrolling participants has halted prematurely)
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01244711
First received: November 18, 2010
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

The hypothesis of this study is that symptoms of anxiety, depression and insomnia; and indices of psychosocial function will all improve, while BZ use will decrease significantly during a twelve-week trial period of substituting quetiapine for benzodiazepines.


Condition Intervention Phase
Major Depression
Generalized Anxiety Disorder
Drug: quetiapine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • MADRS/Ham-A [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    For MDD: The primary efficacy measures will be change from baseline to endpoint in the MADRAS and the change in mean daily benzodiazepine dose in diazepam equivalents during the past week.

    For GAD: The primary efficacy measures will be change from baseline to endpoint in the HAM-A and the change in mean daily benzodiazepine dose in diazepam equivalents during the past week.



Enrollment: 1
Study Start Date: September 2008
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

For inclusion in the study subjects must fulfil all of the following criteria:

  1. Provision of written informed consent
  2. 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.
  3. Females and/or males aged 18-65 years
  4. 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
  5. Able to understand and comply with the requirements of the study
  6. 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:

    1. Pregnancy or lactation
    2. Any DSM-IV Axis I disorder not defined in the inclusion criteria
    3. 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).
    4. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
    5. Known intolerance or lack of response to quetiapine fumarate as judged by the investigator
    6. 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
    7. 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
    8. Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation
    9. Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
    10. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment
    11. Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
    12. Unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by the investigator
    13. Involvement in the planning and conduct of the study
    14. Previous enrolment or randomisation of treatment in the present study.
    15. Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01244711

Locations
United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
AstraZeneca
  More Information

No publications provided

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01244711     History of Changes
Other Study ID Numbers: IRUSQUET0483
Study First Received: November 18, 2010
Last Updated: December 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Weill Medical College of Cornell University:
Major Depression
Generalized Anxiety Disorder
Benzodiazepine
Quetiapine

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Depressive Disorder, Major
Mental Disorders
Behavioral Symptoms
Mood Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 31, 2014