SchizophreniaPhase 4NCT03075657
Study of add-on Ramelteon Therapy on Sleep and Circadian Rhythm Disruption in Patients With Schizophrenia
A Phase 4 study testing Risperidone, Risperidone and Ramelteon and Haloperidol in people with Schizophrenia, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
Trial summary
The proposed study has been planned to evaluate the effect of add-on ramelteon on sleep pattern/quality and circadian rhythm disruption in patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Risperidone, Risperidone and Ramelteon and Haloperidol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- 1 May 2017to 31 Aug 2018
- 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
- All adult patients of either sex with age range 18-65 years with the clinical diagnosis of schizophrenia. (DSM-V)
- Treatment naïve patients or patients who had not taken any treatment for at least 4 weeks before inclusion.
- Legal guardian of patients consenting to participate in the study by signing the informed consent form.
Who cannot join
- Schizoaffective disorder or schizophrenia with somatoform disorders.
- Highly agitated patients who need immediate treatment.
- Patients who are already under treatment for the presenting conditions.
- Patients with comorbid substance abuse or history of organicity
- Patients with known history of dementia, obstructive sleep apnoea syndrome, diabetes mellitus.
- Pregnant and nursing women.
- History of allergy or hypersensitivity to ramelteon.
- Legal guardian of patients not willing to participate in the study.
Trial locations and contacts
1 site in 1 country.
India1 site
All India Institute of Medical Sciences (AIIMS)
Bhubaneswar, Odisha, 751019
About this study
The proposed study has been planned to evaluate the effect of add-on ramelteon on sleep pattern/quality and circadian rhythm disruption in patients with schizophrenia.
Read the detailed description
Schizophrenia is a mental dysfunction of thought, perception and behaviour which can be attributed to complex and dynamically interacting perturbations in multiple neurochemical systems. Along with these cardinal features of schizophrenia, sleep disorders and disturbed circadian rhythm are commonly encountered among patients. Markedly decreased sleep efficiency, delayed sleep onset and frequent awakenings are most common observations. Endogenous melatonin is a dependable biomarker of circadian rhythmicity and, it has already been found that the nocturnal rise of endogenous melatonin is blunted leading to circadian dysrhythmia in schizophrenia.
The antipsychotics prescribed for the condition though cause improvement in the cardinal symptoms of the disease but have no significant effect on melatonin levels. The blunted peak of night time melatonin secretion are not restored or even decreased even after several months therapy with antipsychotics. In this clinical scenario, add-on therapy with sedative/ hypnotics along with antipsychotics is mandate for a prescription. Previous studies revealed that add-on therapy with benzodiazepines can worsen the already existing derangement in circadian rhythm by decreasing secretion of nocturnal melatonin. A long term add on therapy with benzodiazepines in patients on antipsychotics has been found to have an increased risk of death.
Addition of melatonin to the pharmacotherapy of schizophrenia elevates mood and daytime functioning in addition to improved sleep in schizophrenia patients. Melatonin, apart from being a hypnotic and circadian rhythm restoring compound, also possess neuroprotective, anti-neuroinflammatory and antioxidant properties. The rate limiting step of melatonin biosynthetic pathway is the alkylation of serotonin to N- acetyl serotonin, catalyzed by enzyme AANAT (aryl-alkylamine- N-acetyl-transferase). Study of AANAT enzyme and its modulation to achieve normal rhythmical secretion of melatonin can also be a potential target for resynchronising the circadian rhythm.
Ramelteon is a melatonin receptor agonist approved for treatment of insomnia by the USFDA. It exerts its action by acting on MT1 and MT2 receptors at suprachiasmatic nucleus. The long term safety of ramelteon has been evaluated by several workers and found no significant adverse effects like abuse liability, rebound insomnia and cognitive impairment. In contrast to melatonin, it shows higher-binding affinity for MT1 and MT2 receptors, more lipophilic and has a longer half-life(t1/2 of melatonin is 20-50 min whereas that of ramelteon is 1-2.6 hrs and that of its active melabolite M-II is 2-5 hrs). In addition, ramelteon has been already evaluated as a potential adjunctive treatment for learning and memory deficits in schizophrenia.
The sleep and circadian rhythm disorders in schizophrenia have so far been given very less importance by researchers and there are limited studies targeting or modulating the melatonin pathway. Therefore, proposed study has been planned to evaluate the effect of add-on ramelteon on sleep pattern/quality and circadian rhythm disruption in patients with schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- Risperidone, Risperidone and Ramelteon, Haloperidol, Haloperidol and Ramelteon
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisperidoneDrug
Risperidone will be prescribed at dose of 2 mg per day
Risperidone and RamelteonDrug
Ramelteon will be prescribed 8mg/day as an add-on therapy to Risperidone 2 mg per day
HaloperidolDrug
Haloperidol will be prescribed at a dose of 4 mg per day
Haloperidol and RamelteonDrug
Ramelteon will be prescribed 8mg/day as an add-on therapy to Haloperidol 4 mg per day
| Study group | Role | What they receive |
|---|---|---|
| Risperidone group | Active comparator | Schizophrenia patients with predominant negative symptoms on Risperidone monotherapy Receives: Drug: Risperidone |
| Risperidone with Ramelteon group | Experimental | Schizophrenia patients with predominant negative symptoms on Risperidone with add-on Ramelteon therapy Receives: Drug: Risperidone and Ramelteon |
| Haloperidol group | Active comparator | Schizophrenia patients with predominant positive symptoms on Haloperidol monotherapy Receives: Drug: Haloperidol |
| Haloperidol with Ramelteon group | Experimental | Schizophrenia patients with predominant positive symptoms on Haloperidol with add-on Ramelteon therapy Receives: Drug: Haloperidol and Ramelteon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum melatonin over 4 weeks from baseline
ELISA
Measured: Baseline and 4 weeks
Secondary outcomes (4)
Change in quality of sleep over 4 weeks from baseline
Pittsburgh Sleep Quality Index (PSQI) scoring
Measured: Baseline and 4 weeks
Change in urinary melatonin(6MTs) over 4 weeks from baseline
HPLC
Measured: Baseline and 4 weeks
Change in serum AANAT enzyme over 4 weeks from baseline
ELISA
Measured: Baseline and 4 weeks
Change in severity of symptoms of schizophrenia over 4 weeks from baseline
PANSS Scoring
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start1 May 2017
- Primary completion15 Jun 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RITUPARNA MAITI, All India Institute of Medical Sciences, Bhubaneswar
- Investigators
- DEBASISH HOTA, DM, Study chair, AIIMS, BHUBANESWAR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03075657
- Sponsor's protocol ID
- T/IM-NF/Pharma/01/17
- Status last verified
- May 2019
- First submitted
- 6 Mar 2017
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cohrs S. Sleep disturbances in patients with schizophrenia : impact and effect of antipsychotics. CNS Drugs. 2008;22(11):939-62. doi: 10.2165/00023210-200822110-00004.
PubMed 18840034Wehr TA, Aeschbach D, Duncan WC Jr. Evidence for a biological dawn and dusk in the human circadian timing system. J Physiol. 2001 Sep 15;535(Pt 3):937-51. doi: 10.1111/j.1469-7793.2001.t01-1-00937.x.
PubMed 11559786Afonso P, Figueira ML, Paiva T. Sleep-promoting action of the endogenous melatonin in schizophrenia compared to healthy controls. Int J Psychiatry Clin Pract. 2011 Nov;15(4):311-5. doi: 10.3109/13651501.2011.605954. Epub 2011 Aug 28.
PubMed 22122006Wulff K, Dijk DJ, Middleton B, Foster RG, Joyce EM. Sleep and circadian rhythm disruption in schizophrenia. Br J Psychiatry. 2012 Apr;200(4):308-16. doi: 10.1192/bjp.bp.111.096321. Epub 2011 Dec 22.
PubMed 22194182Mann K, Rossbach W, Muller MJ, Muller-Siecheneder F, Pott T, Linde I, Dittmann RW, Hiemke C. Nocturnal hormone profiles in patients with schizophrenia treated with olanzapine. Psychoneuroendocrinology. 2006 Feb;31(2):256-64. doi: 10.1016/j.psyneuen.2005.08.005. Epub 2005 Sep 26.
PubMed 16185814Cohrs S, Pohlmann K, Guan Z, Jordan W, Meier A, Huether G, Ruther E, Rodenbeck A. Quetiapine reduces nocturnal urinary cortisol excretion in healthy subjects. Psychopharmacology (Berl). 2004 Jul;174(3):414-20. doi: 10.1007/s00213-003-1766-6. Epub 2004 Jan 20.
PubMed 14735295Robinson S, Rosca P, Durst R, Shai U, Ghinea C, Schmidt U, Nir I. Serum melatonin levels in schizophrenic and schizoaffective hospitalized patients. Acta Psychiatr Scand. 1991 Sep;84(3):221-4. doi: 10.1111/j.1600-0447.1991.tb03133.x.
PubMed 1950621Monteleone P, Natale M, La Rocca A, Maj M. Decreased nocturnal secretion of melatonin in drug-free schizophrenics: no change after subchronic treatment with antipsychotics. Neuropsychobiology. 1997;36(4):159-63. doi: 10.1159/000119377.
PubMed 9396013Hajak G, Rodenbeck A, Bandelow B, Friedrichs S, Huether G, Ruther E. Nocturnal plasma melatonin levels after flunitrazepam administration in healthy subjects. Eur Neuropsychopharmacol. 1996 May;6(2):149-53. doi: 10.1016/0924-977x(96)00005-3.
PubMed 8791041Kabuto M, Namura I, Saitoh Y. Nocturnal enhancement of plasma melatonin could be suppressed by benzodiazepines in humans. Endocrinol Jpn. 1986 Jun;33(3):405-14. doi: 10.1507/endocrj1954.33.405.
PubMed 3757924Baandrup L, Fagerlund B, Jennum P, Lublin H, Hansen JL, Winkel P, Gluud C, Oranje B, Glenthoj BY. Prolonged-release melatonin versus placebo for benzodiazepine discontinuation in patients with schizophrenia: a randomized clinical trial - the SMART trial protocol. BMC Psychiatry. 2011 Oct 5;11:160. doi: 10.1186/1471-244X-11-160.
PubMed 21975110Lavie P. Melatonin: role in gating nocturnal rise in sleep propensity. J Biol Rhythms. 1997 Dec;12(6):657-65. doi: 10.1177/074873049701200622.
PubMed 9406042Suresh Kumar PN, Andrade C, Bhakta SG, Singh NM. Melatonin in schizophrenic outpatients with insomnia: a double-blind, placebo-controlled study. J Clin Psychiatry. 2007 Feb;68(2):237-41. doi: 10.4088/jcp.v68n0208.
PubMed 17335321Miyamoto M. Pharmacology of ramelteon, a selective MT1/MT2 receptor agonist: a novel therapeutic drug for sleep disorders. CNS Neurosci Ther. 2009 Winter;15(1):32-51. doi: 10.1111/j.1755-5949.2008.00066.x.
PubMed 19228178Johnson MW, Suess PE, Griffiths RR. Ramelteon: a novel hypnotic lacking abuse liability and sedative adverse effects. Arch Gen Psychiatry. 2006 Oct;63(10):1149-57. doi: 10.1001/archpsyc.63.10.1149.
PubMed 17015817
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of add-on Ramelteon Therapy on Sleep and Circadian Rhythm Disruption in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT03075657
- Acronym / sponsor ID
- T/IM-NF/Pharma/01/17
- Conditions
- Schizophrenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- All India Institute of Medical Sciences, BhubaneswarUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 9 Mar 2017 (actual)
- 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.
The proposed study has been planned to evaluate the effect of add-on ramelteon on sleep pattern/quality and circadian rhythm disruption in patients with schizophrenia.
Detailed description
Schizophrenia is a mental dysfunction of thought, perception and behaviour which can be attributed to complex and dynamically interacting perturbations in multiple neurochemical systems. Along with these cardinal features of schizophrenia, sleep disorders and disturbed circadian rhythm are commonly encountered among patients. Markedly decreased sleep efficiency, delayed sleep onset and frequent awakenings are most common observations. Endogenous melatonin is a dependable biomarker of circadian rhythmicity and, it has already been found that the nocturnal rise of endogenous melatonin is blunted leading to circadian dysrhythmia in schizophrenia.
The antipsychotics prescribed for the condition though cause improvement in the cardinal symptoms of the disease but have no significant effect on melatonin levels. The blunted peak of night time melatonin secretion are not restored or even decreased even after several months therapy with antipsychotics. In this clinical scenario, add-on therapy with sedative/ hypnotics along with antipsychotics is mandate for a prescription. Previous studies revealed that add-on therapy with benzodiazepines can worsen the already existing derangement in circadian rhythm by decreasing secretion of nocturnal melatonin. A long term add on therapy with benzodiazepines in patients on antipsychotics has been found to have an increased risk of death.
Addition of melatonin to the pharmacotherapy of schizophrenia elevates mood and daytime functioning in addition to improved sleep in schizophrenia patients. Melatonin, apart from being a hypnotic and circadian rhythm restoring compound, also possess neuroprotective, anti-neuroinflammatory and antioxidant properties. The rate limiting step of melatonin biosynthetic pathway is the alkylation of serotonin to N- acetyl serotonin, catalyzed by enzyme AANAT (aryl-alkylamine- N-acetyl-transferase). Study of AANAT enzyme and its modulation to achieve normal rhythmical secretion of melatonin can also be a potential target for resynchronising the circadian rhythm.
Ramelteon is a melatonin receptor agonist approved for treatment of insomnia by the USFDA. It exerts its action by acting on MT1 and MT2 receptors at suprachiasmatic nucleus. The long term safety of ramelteon has been evaluated by several workers and found no significant adverse effects like abuse liability, rebound insomnia and cognitive impairment. In contrast to melatonin, it shows higher-binding affinity for MT1 and MT2 receptors, more lipophilic and has a longer half-life(t1/2 of melatonin is 20-50 min whereas that of ramelteon is 1-2.6 hrs and that of its active melabolite M-II is 2-5 hrs). In addition, ramelteon has been already evaluated as a potential adjunctive treatment for learning and memory deficits in schizophrenia.
The sleep and circadian rhythm disorders in schizophrenia have so far been given very less importance by researchers and there are limited studies targeting or modulating the melatonin pathway. Therefore, proposed study has been planned to evaluate the effect of add-on ramelteon on sleep pattern/quality and circadian rhythm disruption in patients with schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Risperidone group | Active comparator | Drug: RisperidoneSchizophrenia patients with predominant negative symptoms on Risperidone monotherapy |
| Risperidone with Ramelteon group | Experimental | Drug: Risperidone and RamelteonSchizophrenia patients with predominant negative symptoms on Risperidone with add-on Ramelteon therapy |
| Haloperidol group | Active comparator | Drug: HaloperidolSchizophrenia patients with predominant positive symptoms on Haloperidol monotherapy |
| Haloperidol with Ramelteon group | Experimental | Drug: Haloperidol and RamelteonSchizophrenia patients with predominant positive symptoms on Haloperidol with add-on Ramelteon therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All adult patients of either sex with age range 18-65 years with the clinical diagnosis of schizophrenia. (DSM-V)
- Treatment naïve patients or patients who had not taken any treatment for at least 4 weeks before inclusion.
- Legal guardian of patients consenting to participate in the study by signing the informed consent form.
Key exclusion criteria (8 listed)
- Schizoaffective disorder or schizophrenia with somatoform disorders.
- Highly agitated patients who need immediate treatment.
- Patients who are already under treatment for the presenting conditions.
- Patients with comorbid substance abuse or history of organicity
- Patients with known history of dementia, obstructive sleep apnoea syndrome, diabetes mellitus.
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 |
|---|---|---|
| RisperidoneRisperidone will be prescribed at dose of 2 mg per day | Drug | Risperidone group |
| Risperidone and RamelteonRamelteon will be prescribed 8mg/day as an add-on therapy to Risperidone 2 mg per day | Drug | Risperidone with Ramelteon group |
| HaloperidolHaloperidol will be prescribed at a dose of 4 mg per day | Drug | Haloperidol group |
| Haloperidol and RamelteonRamelteon will be prescribed 8mg/day as an add-on therapy to Haloperidol 4 mg per day | Drug | Haloperidol with Ramelteon group |
Primary outcome
Change in serum melatonin over 4 weeks from baseline
Time frame: Baseline and 4 weeks
ELISA
4 secondary outcomes
Change in quality of sleep over 4 weeks from baseline
Time frame: Baseline and 4 weeks
Change in urinary melatonin(6MTs) over 4 weeks from baseline
Time frame: Baseline and 4 weeks
Change in serum AANAT enzyme over 4 weeks from baseline
Time frame: Baseline and 4 weeks
Change in severity of symptoms of schizophrenia over 4 weeks from baseline
Time frame: Baseline and 4 weeks
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 3 May 2019.
- Results publication: PubMed 18840034Cohrs S. Sleep disturbances in patients with schizophrenia : impact and effect of antipsychotics. CNS Drugs. 2008;22(11):939-62. doi: 10.2165/00023210-200822110-00004.
- Results publication: PubMed 11559786Wehr TA, Aeschbach D, Duncan WC Jr. Evidence for a biological dawn and dusk in the human circadian timing system. J Physiol. 2001 Sep 15;535(Pt 3):937-51. doi: 10.1111/j.1469-7793.2001.t01-1-00937.x.
- Results publication: PubMed 22122006Afonso P, Figueira ML, Paiva T. Sleep-promoting action of the endogenous melatonin in schizophrenia compared to healthy controls. Int J Psychiatry Clin Pract. 2011 Nov;15(4):311-5. doi: 10.3109/13651501.2011.605954. Epub 2011 Aug 28.
- Results publication: PubMed 22194182Wulff K, Dijk DJ, Middleton B, Foster RG, Joyce EM. Sleep and circadian rhythm disruption in schizophrenia. Br J Psychiatry. 2012 Apr;200(4):308-16. doi: 10.1192/bjp.bp.111.096321. Epub 2011 Dec 22.
- Results publication: PubMed 16185814Mann K, Rossbach W, Muller MJ, Muller-Siecheneder F, Pott T, Linde I, Dittmann RW, Hiemke C. Nocturnal hormone profiles in patients with schizophrenia treated with olanzapine. Psychoneuroendocrinology. 2006 Feb;31(2):256-64. doi: 10.1016/j.psyneuen.2005.08.005. Epub 2005 Sep 26.
- Results publication: PubMed 14735295Cohrs S, Pohlmann K, Guan Z, Jordan W, Meier A, Huether G, Ruther E, Rodenbeck A. Quetiapine reduces nocturnal urinary cortisol excretion in healthy subjects. Psychopharmacology (Berl). 2004 Jul;174(3):414-20. doi: 10.1007/s00213-003-1766-6. Epub 2004 Jan 20.
- Results publication: PubMed 1950621Robinson S, Rosca P, Durst R, Shai U, Ghinea C, Schmidt U, Nir I. Serum melatonin levels in schizophrenic and schizoaffective hospitalized patients. Acta Psychiatr Scand. 1991 Sep;84(3):221-4. doi: 10.1111/j.1600-0447.1991.tb03133.x.
- Results publication: PubMed 9396013Monteleone P, Natale M, La Rocca A, Maj M. Decreased nocturnal secretion of melatonin in drug-free schizophrenics: no change after subchronic treatment with antipsychotics. Neuropsychobiology. 1997;36(4):159-63. doi: 10.1159/000119377.
- Results publication: PubMed 8791041Hajak G, Rodenbeck A, Bandelow B, Friedrichs S, Huether G, Ruther E. Nocturnal plasma melatonin levels after flunitrazepam administration in healthy subjects. Eur Neuropsychopharmacol. 1996 May;6(2):149-53. doi: 10.1016/0924-977x(96)00005-3.
- Results publication: PubMed 3757924Kabuto M, Namura I, Saitoh Y. Nocturnal enhancement of plasma melatonin could be suppressed by benzodiazepines in humans. Endocrinol Jpn. 1986 Jun;33(3):405-14. doi: 10.1507/endocrj1954.33.405.
- Results publication: PubMed 21975110Baandrup L, Fagerlund B, Jennum P, Lublin H, Hansen JL, Winkel P, Gluud C, Oranje B, Glenthoj BY. Prolonged-release melatonin versus placebo for benzodiazepine discontinuation in patients with schizophrenia: a randomized clinical trial - the SMART trial protocol. BMC Psychiatry. 2011 Oct 5;11:160. doi: 10.1186/1471-244X-11-160.
- Results publication: PubMed 9406042Lavie P. Melatonin: role in gating nocturnal rise in sleep propensity. J Biol Rhythms. 1997 Dec;12(6):657-65. doi: 10.1177/074873049701200622.
- Individual participant dataSharing planned: No
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.
DEBASISH HOTA, DM study chair
AIIMS, BHUBANESWAR
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 Risperidone, Risperidone and Ramelteon and Haloperidol in people with Schizophrenia, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
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 8 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 3 May 2019. 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 India. 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?
Change in serum melatonin over 4 weeks from baseline (time frame: Baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03075657, which also lists 18 linked publications.
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 3 May 2019.