First Episode Schizophrenia and Cannabis-Related Disorder Study

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00573287
First received: December 12, 2007
Last updated: March 1, 2013
Last verified: March 2013
  Purpose

Many individuals with schizophrenia abuse cannabis at the onset of their illness, portending a poorer course of illness and poorer treatment response. Preliminary evidence suggests that clozapine may uniquely reduce substance use in patients with schizophrenia. The purpose of this study is to establish an effective methodology for studying early treatment with clozapine in patients with co-occurring schizophrenia and cannabis use disorder, while generating pilot data comparing clozapine vs. risperidone on substance use, psychiatric symptoms, side effects, and treatment discontinuation.


Condition Intervention
Cannabis-Related Disorder
Substance-Related Disorders
Schizophrenia
Psychotic Disorders
Drug: clozapine
Drug: risperidone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clozapine Vs. Risperidone for People With First Episode Schizophrenia and Co-Occurring Substance Use Disorder

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Number of Participants Demonstrating Improvement in Substance Use [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Based on the small sample size, it was not possible to test the differences between the two groups for statistical significance. Data on cannabis use was gathered weekly using the TLFB method. At the end of the study, graphs were plotted showing days of cannabis use per week and rated as "Improved," "Unchanged," or "Worse" by a pair of expert judges. Raters were instructed to rate the graph "Improved" or "Worsened" if it appeared to be >20% better or worse and to rate it "Unchanged" if there was little or no change (less than ~20%).


Secondary Outcome Measures:
  • Psychiatric Symptoms Measured Using the Brief Psychiatric Rating Scale, Clinical Global Inventory, and Schedule for the Assessment of Negative Symptoms at Baseline and Then at Weeks 4, 8, 12, 16, 20, and 24. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 14
Study Start Date: June 2006
Study Completion Date: December 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Clozapine
clozapine: clozapine--tablets, 12.5-100 mg, daily for 24 weeks
Drug: clozapine
clozapine--tabs, 450mg. max, daily, 24 weeks
Other Name: Clozaril
Active Comparator: Risperidone
risperidone: risperidone--tablets, 0.5-5.0mg daily for 24 weeks
Drug: risperidone
risperidone--tabs, 6mg max, daily, 24 weeks
Other Name: Risperdal

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   17 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 17 - 45
  • Meets DSM-IV criteria for schizophrenia or schizoaffective disorder
  • Currently within the first episode of schizophrenia ("First Episode" is defined as having onset with the first evidence of psychotic symptoms by history, and the first episode will have ended if the CGI has been < 2 and there has been no rating > 2 on any one of the BPRS psychotic items for 6 weeks or longer)
  • Meets DSM-IV criteria for cannabis use disorder
  • Cannabis use within the five weeks prior to recruitment (screening visit or hospital admission) by self-report (TLFB), collateral report, or drug screen.
  • Requires treatment with an antipsychotic medication
  • Patients (or guardians) must provide informed consent prior to entry into the study

Exclusion Criteria:

  • Medical contraindications to treatment with clozapine or risperidone, including previous paralytic ileus.
  • Cumulative treatment with antipsychotic medication in excess of 16 weeks prior to hospital admission (or case identification if an outpatient), unless waived by the MAG
  • History of allergic reaction to clozapine or risperidone
  • History of seizure disorder or blood dyscrasia. Note: If patients have a history of seizures, but not a diagnosed seizure disorder, they may be admitted to the study if approved by the MAG.
  • Current treatment with clozapine
  • Currently pregnant, planning to become pregnant, or unwilling to use an acceptable form of birth control.
  • Currently residing in a residential program designed to treat substance use disorders.
  • Treatment at baseline with a psychotropic agent proposed to curtail substance use (e.g. disulfiram, naltrexone, valproic acid, topiramate, acamprosate or benzodiazepines) will require a review by the medication adjustment group before entering the client into the study
  • Patients who, in the opinion of the investigator, are judged unsuitable to participate in the study (For example, patients who are actively homicidal or have a pending incarceration that would prevent them from participating in the study)
  • History of, or current breast cancer
  • People who are doing well on current therapy
  • Lack of an identifiable primary family/support person, and unable to come to a study site for weekly visits
  • Treatment with serotonin re-uptake inhibitors will not be excluded but requires a review by the MAG prior to randomization.
  • Patients with current cocaine dependence will require review by the MAG to determine stability for the study.
  • Treatment with multiple antipsychotics or long acting injectable antipsychotic at baseline is not excluded, but will be reviewed by the MAG to assess appropriateness for the study.
  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: NCT00573287

Locations
United States, New Hampshire
New Hampshire Hospital
Concord, New Hampshire, United States, 03301
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
West Central Behavioral Health
Lebanon, New Hampshire, United States, 03766
Mental Health Center of Greater Manchester
Manchester, New Hampshire, United States, 03101
Center for Psychiatric Advancement & Community Council of Nashua
Nashua, New Hampshire, United States, 03060
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Alan I. Green, MD Dartmouth-Hitchcock Medical Center
Study Director: Doug Noordsy, MD Dartmouth-Hitchcock Medical Center
  More Information

No publications provided

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00573287     History of Changes
Obsolete Identifiers: NCT00063349
Other Study ID Numbers: MG 62157-02, MG 62157-02
Study First Received: December 12, 2007
Results First Received: January 16, 2013
Last Updated: March 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dartmouth-Hitchcock Medical Center:
Clozapine, risperidone, first episode,

Additional relevant MeSH terms:
Marijuana Abuse
Psychotic Disorders
Mental Disorders
Schizophrenia
Substance-Related Disorders
Chemically-Induced Disorders
Schizophrenia and Disorders with Psychotic Features
Clozapine
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
GABA Antagonists
GABA Agents
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on August 28, 2014