SchizophreniaPhase 4NCT00222794
A Clinical Trial to Examine Effects of Atomoxetine in the Treatment of Negative Symptoms in Patients With Schizophrenia
A Phase 4 study testing Atomoxetine (Strattera) in people with Schizophrenia and Schizoaffective Disorder, run by University of Pittsburgh at 1 site in United States.
Trial summary
This study proposes to examine the effect of atomoxetine on quality of life and negative symptoms such as social withdrawal, lack of interest in things, lack of thought content, flat emotions, slowed body movements and lack of drive and motivation in patients with schizophrenia or schizoaffective disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Atomoxetine (Strattera)
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2003to Jul 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female.
- Ages 18-65 years inclusive.
- No psychiatric hospitalization in the past 30 days.
- Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnosis of schizophrenia.
- Total Positive and Negative Syndrome Scale (PANSS) score of 80 or less on entry.
- Currently receiving a stable dose of antipsychotic(s) for at least 30 days prior to randomization.
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- Receiving a stable dose of psychotropic medication for at least 30 days
- Female patients of childbearing age must be using an acceptable method of birth control.
- A minimum score of 10 on five global ratings of the Scale for the Assessment of Negative Symptoms (SANS) with minimum score of at least 3 on two of the global items and a mean score of 4 or less for General Life Satisfaction on the Lehman's quality of life (QOL) interview.
Who cannot join
- Inability to give informed consent.
- Current alcohol or substance abuse or dependence within the last 6 months.
- History of narrow angle glaucoma or organic brain disease.
- Female patient of childbearing potential without adequate contraception.
- Uncontrolled diabetes mellitus (a fasting blood glucose of >126mg/dL), uncontrolled hypertension (a systolic of >160mm/hg and a diastolic of >100mm/hg) or orthostatic hypotension, assessed on a case by case basis, liver disease (AST of > 40 u/L, and ALT of > 56 u/L), cerebrovascular disorder or myocardial infarction diagnosed 3 months prior to study entry.
- Concurrently receiving treatment with venlafaxine (Effexor), a MAO inhibitor such as Nardil (phenelzine), or Parnate (tranylcypromine), cytochrome p450 2d6 inhibitors such as fluoxetine (Prozac, Sarafem), paroxetine (Paxil), or quinidine (Cardioquin, Quinidex Extentabs), albuterol (Ventolin, Proventil, Combivent, AccuNeb, Serevent) and all psychostimulants (dextroamphetamine and methylphenidate) currently or within the last 2 weeks.
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, 15213
About this study
Official title: A Randomized, Parallel Group, Double Blind, Placebo Controlled, Clinical Trial of Augmentation With Atomoxetine for the Treatment of Negative Symptoms in Patients With Schizophrenia and Schizoaffective Disorder
This study proposes to examine the effect of atomoxetine on quality of life and negative symptoms such as social withdrawal, lack of interest in things, lack of thought content, flat emotions, slowed body movements and lack of drive and motivation in patients with schizophrenia or schizoaffective disorder. This study also examines the safety of using atomoxetine along with the conventional antipsychotic in these patients.
Read the detailed description
This study proposes to examine the effect of Atomoxetine (Strattera), a selective norepinephrine reuptake inhibitor on Negative Symptoms and Quality of Life and its safety when used in conjunction with an atypical antipsychotic agent in remitted community dwelling subjects with Schizophrenia or Schizoaffective disorder. Atomoxetine was recently approved by the FDA for the treatment of Attention Deficit Hyperactivity Disorder in children and adults. All subjects will receive various psychometric assessments at 2-week intervals for a period of 26 weeks. It is hypothesized that subjects treated with Atomoxetine in this 26 week random assignment, parallel-group, double-blind, placebo-controlled study, will have a significantly greater improvement in quality of life and social functioning.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Atomoxetine (Strattera)
- Keywords
- Schizophrenia, Schizo-Affective Disorder, Negative Symptoms, Atomoxetine, Strattera
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atomoxetine (Strattera)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine efficacy of atomoxetine as an adjunct agent in treatment of negative symptoms in subjects with schizophrenia or schizoaffective disorder.
Secondary outcomes (3)
To examine the effect of atomoxetine therapy on quality of life
To examine safety of adjunctive treatment with atomoxetine
To examine the effects of atomoxetine therapy on other domains of psychopathology (positive symptoms, depressive symptoms, general psychopathology).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startNov 2003
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 66 participants
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Stanley Medical Research Institute
- Investigators
- Rohan Ganguli, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00222794
- Sponsor's protocol ID
- 0308023
- Other IDs
- 03T-327
- Status last verified
- Jan 2008
- First submitted
- 8 Sep 2005
- Last updated
- 31 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel Group, Double Blind, Placebo Controlled, Clinical Trial of Augmentation With Atomoxetine for the Treatment of Negative Symptoms in Patients With Schizophrenia and Schizoaffective Disorder
- ClinicalTrials.gov ID
- NCT00222794
- Acronym / sponsor ID
- 0308023
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Schizophrenia, Schizo-Affective Disorder, Negative Symptoms, Atomoxetine, Strattera
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Stanley Medical Research Institute
- Study start
- Nov 2003
- Study completion
- Jul 2006 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study proposes to examine the effect of atomoxetine on quality of life and negative symptoms such as social withdrawal, lack of interest in things, lack of thought content, flat emotions, slowed body movements and lack of drive and motivation in patients with schizophrenia or schizoaffective disorder. This study also examines the safety of using atomoxetine along with the conventional antipsychotic in these patients.
Detailed description
This study proposes to examine the effect of Atomoxetine (Strattera), a selective norepinephrine reuptake inhibitor on Negative Symptoms and Quality of Life and its safety when used in conjunction with an atypical antipsychotic agent in remitted community dwelling subjects with Schizophrenia or Schizoaffective disorder. Atomoxetine was recently approved by the FDA for the treatment of Attention Deficit Hyperactivity Disorder in children and adults. All subjects will receive various psychometric assessments at 2-week intervals for a period of 26 weeks. It is hypothesized that subjects treated with Atomoxetine in this 26 week random assignment, parallel-group, double-blind, placebo-controlled study, will have a significantly greater improvement in quality of life and social functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female.
- Ages 18-65 years inclusive.
- No psychiatric hospitalization in the past 30 days.
- Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnosis of schizophrenia.
- Total Positive and Negative Syndrome Scale (PANSS) score of 80 or less on entry.
Key exclusion criteria (6 listed)
- Inability to give informed consent.
- Current alcohol or substance abuse or dependence within the last 6 months.
- History of narrow angle glaucoma or organic brain disease.
- Female patient of childbearing potential without adequate contraception.
- Uncontrolled diabetes mellitus (a fasting blood glucose of >126mg/dL), uncontrolled hypertension (a systolic of >160mm/hg and a diastolic of >100mm/hg) or orthostatic hypotension, assessed on a case by case basis, liver disease (AST of > 40 u/L, and ALT of > 56 u/L), cerebrovascular disorder or myocardial infarction diagnosed 3 months prior to study entry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atomoxetine (Strattera) | Drug | – |
Primary outcome
To examine efficacy of atomoxetine as an adjunct agent in treatment of negative symptoms in subjects with schizophrenia or schizoaffective disorder.
3 secondary outcomes
To examine the effect of atomoxetine therapy on quality of life
To examine safety of adjunctive treatment with atomoxetine
To examine the effects of atomoxetine therapy on other domains of psychopathology (positive symptoms, depressive symptoms, general psychopathology).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rohan Ganguli, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atomoxetine (Strattera) in people with Schizophrenia and Schizoaffective Disorder, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To examine efficacy of atomoxetine as an adjunct agent in treatment of negative symptoms in subjects with schizophrenia or schizoaffective disorder.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2010.