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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Major Depression; Generalized Anxiety Disorder	Drug: quetiapine	Phase 4

  Show Detailed Description

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.	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

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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).

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Investigators

Principal Investigator:	james h kocsis, md	weill cornell mc

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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