Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01172652
Other study ID # SUP0005-17504
Secondary ID
Status Completed
Phase Phase 4
First received April 16, 2010
Last updated March 16, 2012
Start date April 2010
Est. completion date October 2011

Study information

Verified date March 2012
Source VA Palo Alto Health Care System
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The specific aim of this study is to evaluate the efficacy, tolerability, and safety of ziprasidone monotherapy in comparison to placebo in the treatment of ambulatory bipolar disorder with co-morbid lifetime panic disorder or generalized anxiety disorder and current at least moderately severe anxiety.


Description:

This is a randomized, double-blind, placebo controlled, parallel-group, 8-week trial of ziprasidone compared to placebo in outpatient subjects with a lifetime bipolar I, II, or NOS disorder, a lifetime panic or generalized anxiety disorder, and current diagnosis at least moderately severe anxiety symptoms. Approximately 50 subjects will be randomized. Subjects will be randomized to ziprasidone or placebo in a 1:1 ratio. No concomitant psychotropic medication will be allowed throughout the study except for prn lorazepam during the first two weeks for the management of affective and anxiety symptoms, prn zolpidem and zaleplon for the management of insomnia and benztropine for the management of EPS. Throughout the study, psychiatric scales will be used to assess psychiatric symptoms and the presence of treatment-emergent adverse events will be monitored and recorded.


Recruitment information / eligibility

Status Completed
Enrollment 49
Est. completion date October 2011
Est. primary completion date October 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Subjects must at least age of 18 years of age and not older than 65.

- Subjects must have lifetime bipolar I, II, or NOS disorder as defined by DSM-IV TR criteria (26).

- Subjects must have lifetime panic disorder or generalized anxiety disorder (GAD) as defined by DSM-IV criteria (except clause "does not occur exclusively during a mood disorder" of Criterion F for GAD).

- Subjects' bipolar symptoms must be no more than moderate in severity, defined as a CGI-BP< 4 (27).

- Subjects' anxiety symptoms must be at least moderate in severity, defined as a CGI-S > 4 (28).

- Subjects must not be receiving regular mood stabilizing, antidepressant, antipsychotic, or anxiolytic medication for at least one week prior to baseline. Patients receiving fluoxetine or depot antipsychotics should be off these medications for at least four weeks prior to baseline.

- Subjects or their legally authorized representative must sign the Informed Consent Document after the nature of the trial has been fully explained.

- If female, subjects must be: postmenopausal, surgically incapable of childbearing, or practicing medically acceptable effective method(s) of contraception (e.g., hormonal methods, barrier methods, intrauterine device) for at least one month prior to study entry and throughout the study.

Exclusion Criteria:

- Subjects who do not have lifetime bipolar disorder by DSM-IV-TR criteria (26).

- Subjects who do not have lifetime panic disorder or generalized anxiety disorder by DSM-IV-TR criteria (26).

- Subjects who are receiving treatment with an anti-manic or mood stabilizing medication (lithium, valproate, carbamazepine, or an antipsychotic), and in the investigators' judgment, require ongoing treatment with that medication.

- Subjects whose bipolar symptoms are presently more than moderately severe (CGI-BP > 5) (27).

- Subjects whose anxiety symptoms are presently less than moderately severe (CGI-S < 3) (28).

- Subjects with clinically significant suicidal or homicidal ideation.

- Subjects with a current DSM-IV TR Axis I diagnosis of delirium, dementia, amnesia, or other cognitive disorders; a DSM-IV TR diagnosis of a substance dependence disorder within the past six months; a lifetime DSM-IV TR psychotic disorder (e.g., schizophrenia or schizoaffective disorder).

- Subjects with serious general medical illnesses including hepatic, renal, respiratory, cardiovascular, endocrine, neurological, or hematological disease as determined by the clinical judgment of the clinical investigator. Subjects with hypo- or hyperthyroidism unless stabilized on thyroid replacement > 3 months.

- Subjects with a clinically significant abnormality in their pre-study physical exam, vital signs, EKG, or laboratory tests.

- Subjects who are allergic to or who have demonstrated hypersensitivity or intolerance to ziprasidone.

- Women who are pregnant or nursing.

- Subjects who have received an experimental drug or used an experimental device within 30 days.

- Subjects who have a history of neuroleptic malignant syndrome.

- A patient with diabetes mellitus (DM) fulfilling one of the following criteria:

- Unstable DM defined as enrollment glycosylated hemoglobin (HbAlc) >8.5%

- Admitted to hospital for treatment of DM or DM related illness within the past 12 weeks

- Not under physician care for DM

- Physician responsible for patient's DM care has not indicated that the patient's DM is controlled

- Physician responsible for patient's DM care has not approved the patient's participation in the study

- Has not been on the same dose of oral hypoglycemic drug(s) and/or diet for the 4 weeks before randomization. For thiazolidinediones(glitazones)this period should not be less than 8 weeks before randomization.

- Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks

Note: If a patient with DM meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study

Study Design


Intervention

Drug:
Ziprasidone
The minimum dose during study participation will be 40 mg/day, and the maximum dose allowed will be 160 mg/day.
Placebo
Inactive control

Locations

Country Name City State
United States Lindner Center of Hope University of Cincinnati Medical Center Mason Ohio
United States VA Palo Alto Health Care System & Stanford School of Medicine Palo Alto California
United States University of South Florida Institute for Research in Psychiatry Tampa Florida

Sponsors (4)

Lead Sponsor Collaborator
VA Palo Alto Health Care System Lindner Center of HOPE, Pfizer, University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary CGI-21 The primary outcome measure is the Clinician Global Improvement Scale for Anxiety Symptoms (CGI-21) 8 weeks
Secondary Sheehan Panic Disorder Scale (SPS), (HAM-A), Young Mania Rating Scale (YMRS), Sheehan Irritability Scale (SIS), Rapid Ideas Scale RISC, MADRS, PGI-21 symptoms, CGI-BP, Family Impact Scale (FIS), Sheehan Disability Scale (SDS). Sheehan Panic Disorder Scale (SPS), (HAM-A), Young Mania Rating Scale (YMRS), Sheehan Irritability Scale (SIS), Rapid Ideas Scale RISC, MADRS, PGI-21 for anxiety symptoms, CGI-BP, Family Impact Scale (FIS), Sheehan Disability Scale (SDS). 8 weeks
See also
  Status Clinical Trial Phase
Completed NCT05111548 - Brain Stimulation and Cognitive Training - Efficacy N/A
Completed NCT02855762 - Targeting the Microbiome to Improve Clinical Outcomes in Bipolar Disorder N/A
Recruiting NCT05915013 - Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response Phase 1
Recruiting NCT05206747 - Ottawa Sunglasses at Night for Mania Study N/A
Completed NCT02513654 - Pharmacokinetics, Safety and Tolerability of Repeat Dosing Lamotrigine in Healthy Chinese Subjects Phase 1
Recruiting NCT06313918 - Exercise Therapy in Mental Disorders-study N/A
Completed NCT02304432 - Targeting a Genetic Mutation in Glycine Metabolism With D-cycloserine Early Phase 1
Recruiting NCT06197048 - Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia/Psychosis or Bipolar Affective Disorder N/A
Completed NCT03497663 - VIA Family - Family Based Early Intervention Versus Treatment as Usual N/A
Completed NCT04284813 - Families With Substance Use and Psychosis: A Pilot Study N/A
Completed NCT02212041 - Electronic Cigarettes in Smokers With Mental Illness N/A
Recruiting NCT05030272 - Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings N/A
Recruiting NCT04298450 - ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention N/A
Active, not recruiting NCT03641300 - Efficacy of Convulsive Therapies for Bipolar Depression N/A
Not yet recruiting NCT04432116 - Time and Virtual Reality in Schizophrenia and Bipolar Disorder N/A
Terminated NCT02893371 - Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies
Terminated NCT02909504 - Gao NARASD Lithium Study Phase 4
Completed NCT02970721 - Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder
Recruiting NCT02481245 - BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study Phase 2
Recruiting NCT03088657 - Design and Methods of the Mood Disorder Cohort Research Consortium (MDCRC) Study