SchizophreniaEarly Phase 1NCT00456976
Efficacy of Selegiline in Negative Symptoms of Schizophrenia
A Early Phase 1 study testing Selegiline in people with Schizophrenia, run by Tabriz University at 1 site in Iran.
Trial summary
Antipsychotic drugs are effective in treating the positive symptoms of schizophrenia; however their efficacy in treating negative symptoms is limited. This study wants to evaluate efficacy of selegiline augmentation of antipsychotic medication to treat negative symptoms in inpatients with chronic schizophrenia. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Selegiline
- How many people
- 70 participants
- Where
- 1 siteIran
- Study dates
- Apr 2007to Sep 2007
- Phase
- Early Phase 1
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with moderate to severe negative symptoms
- Patients with at least one year antipsychotic drug therapy, at the current dose >= 1 month.
- No other psychotropic drugs during past month
Who cannot join
- Severe major depressive disorder
- Substance abuse
- Severe positive symptoms of schizophrenia
- Treatment of MDD with antidepressant drugs during past month.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Selegiline Augmentation of Antipsychotic Medication to Treat Negative Symptoms in Inpatients With Chronic Schizophrenia
Antipsychotic drugs are effective in treating the positive symptoms of schizophrenia; however their efficacy in treating negative symptoms is limited. This study wants to evaluate efficacy of selegiline augmentation of antipsychotic medication to treat negative symptoms in inpatients with chronic schizophrenia. With randomized clinical trial two groups of patients will select to receive selegiline or placebo.
Primary end point is decreasing in negative symptoms in case group. Inclusion criteria : 1- Patients with moderate to severe negative symptoms 2- Patients with at least one year antipsychotic drug therapy, at the current dose >= 1 month. 3- No other psychotropic drugs during past month. Exclusion criteria: 1- Severe major depressive disorder, substance abuse, severe positive symptoms of schizophrenia, Treatment of MDD with antidepressant drugs during past month.
- Conditions
- Schizophrenia
- Being tested
- Selegiline
- Keywords
- Seligiline, Negative symptoms, Schizopherenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelegilineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
decreasing in negative symptoms in case group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2007 (estimated)
- Study startApr 2007
- Study completionSep 2007
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.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- Tabriz University
- Sponsor type
- University, hospital or other
- Investigators
- Fatemeh Ranjbar Kouchaksaraei, Assistant Professor, Study chair, Tabriz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00456976
- Sponsor's protocol ID
- 8514
- Other IDs
- tums
- Status last verified
- Jul 2008
- First submitted
- 4 Apr 2007
- Last updated
- 23 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Selegiline Augmentation of Antipsychotic Medication to Treat Negative Symptoms in Inpatients With Chronic Schizophrenia
- ClinicalTrials.gov ID
- NCT00456976
- Acronym / sponsor ID
- 8514
- Conditions
- Schizophrenia
- Keywords
- Seligiline, Negative symptoms, Schizopherenia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants
- Lead sponsor
- Tabriz UniversityUniversity, hospital or other
- Study start
- Apr 2007
- Study completion
- Sep 2007
- First posted
- 5 Apr 2007 (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.
Antipsychotic drugs are effective in treating the positive symptoms of schizophrenia; however their efficacy in treating negative symptoms is limited. This study wants to evaluate efficacy of selegiline augmentation of antipsychotic medication to treat negative symptoms in inpatients with chronic schizophrenia. With randomized clinical trial two groups of patients will select to receive selegiline or placebo.
Primary end point is decreasing in negative symptoms in case group. Inclusion criteria : 1- Patients with moderate to severe negative symptoms 2- Patients with at least one year antipsychotic drug therapy, at the current dose >= 1 month. 3- No other psychotropic drugs during past month. Exclusion criteria: 1- Severe major depressive disorder, substance abuse, severe positive symptoms of schizophrenia, Treatment of MDD with antidepressant drugs during past month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with moderate to severe negative symptoms
- Patients with at least one year antipsychotic drug therapy, at the current dose >= 1 month.
- No other psychotropic drugs during past month
Key exclusion criteria (4 listed)
- Severe major depressive disorder
- Substance abuse
- Severe positive symptoms of schizophrenia
- Treatment of MDD with antidepressant drugs during past month.
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 |
|---|---|---|
| Selegiline | Drug | – |
Primary outcome
decreasing in negative symptoms in case group
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 23 Jul 2008.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
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.
Fatemeh Ranjbar Kouchaksaraei, Assistant Professor study chair
Tabriz University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Selegiline in people with Schizophrenia, run by Tabriz University at 1 site in Iran.
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 3 inclusion and 4 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 23 Jul 2008. 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 Iran. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
decreasing in negative symptoms in case group. 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 23 Jul 2008.